Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
Sponsor
FibroGen (Industry)
Overall Status
Completed
CT.gov ID
NCT01414075
Collaborator
Astellas Pharma Inc (Industry)
60
7
4
17.7
8.6
0.5
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Participants on hemodialysis (HD) will be randomized to 3 treatment arms (A, B, and C) of in a 1:1:1 ratio to receive no iron supplementation, oral iron supplementation, and IV iron supplementation, respectively, in addition to roxadustat. At the same time, participants on peritoneal dialysis (PD) will be enrolled into Arm D. Arm E will enroll either HD or PD participants, and is an optional, confirmatory/supplemental treatment arm with flexible dosing and flexible iron supplementation based on the evaluation of data from the previous 4 treatment arms.
Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low weight [40 to 60 kilograms ], medium weight [>60 to 90 kg], and heavy weight [>90 to 140 kg] participants will receive 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 140, 200, and 300 mg for low, medium, and high weight participants, respectively) during Weeks 5 and 9, depending on the hemoglobin (Hb) level and rate of Hb rise in the previous 4 weeks.
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Open-Label, Dose Titration, Safety and Efficacy Study of FG-4592 for the Correction of Anemia in Newly Initiated Dialysis Patients Not on Erythropoiesis-Stimulating Agent Treatment
Actual Study Start Date
:
Jul 21, 2011
Actual Primary Completion Date
:
Jan 10, 2013
Actual Study Completion Date
:
Jan 10, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A + E (Participants on HD): Roxadustat Only, No Iron Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally 3 times weekly (TIW) for 12 weeks. |
Drug: Roxadustat
Tiered, weight-based dosing per schedule specified in the arm.
Other Names:
|
| Experimental: Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
Drug: Roxadustat
Tiered, weight-based dosing per schedule specified in the arm.
Other Names:
Drug: Oral Iron
Administered per oral dose and schedule specified in the arm.
|
| Experimental: Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. |
Drug: Roxadustat
Tiered, weight-based dosing per schedule specified in the arm.
Other Names:
Drug: IV Iron
Administered per IV dose and schedule specified in the arm.
|
| Experimental: Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg Participants on PD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
Drug: Roxadustat
Tiered, weight-based dosing per schedule specified in the arm.
Other Names:
Drug: Oral Iron
Administered per oral dose and schedule specified in the arm.
|
Outcome Measures
Primary Outcome Measures
- Maximum Change From Baseline in Hb During Weeks 3-13 [Baseline, Weeks 3-13]
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation.
Secondary Outcome Measures
- Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 [Baseline, Weeks 2-5, 6-9, and 10-13]
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
- Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL [Week 3 to 13]
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
- Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL [Week 3 to 13]
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
- Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 [Weeks 5, 9, and 13]
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
- Number of Participants Who Achieved Maximum Hb During Weeks 3-13 [Weeks 3-13]
- Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 [Baseline, Weeks 3-13]
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: <1 g/dL, ≥1 g/dL, 1 to <2 g/dL, 2 to <3 g/dL, >3 to <4 g/dL, ≥4 g/dL.
- Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) [Baseline up to Week 13]
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
- Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) [Baseline up to Week 13]
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
- Number of Participants Requiring Dose Increase at Weeks 5 and 9 [Weeks 5 and 9]
Number of participants requiring dose increase due to any reasons is reported.
- Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis [Weeks 5 and 9]
Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported.
- Change From Baseline in Ferritin at Week 13 [Baseline, Week 13]
Baseline was defined as the average of the last 2 values prior to the first dose administration.
- Change From Baseline in Transferrin Saturation (TSAT) at Week 13 [Baseline, Week 13]
- Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 [Baseline, Week 13]
- Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 [Weeks 6-9 and 10-13]
- Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL [Weeks 10-13]
- Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL [Weeks 10-13]
- Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 [Weeks 6-9 and 10-13]
- Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 [Weeks 6-9 and 10-13]
- Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) [Baseline up to Week 13]
Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported.
- Number of Participants Requiring Therapeutic Phlebotomy [Baseline up to Week 13]
Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported.
- Number of Participants Withdrawn From the Study Due to Inadequate Efficacy [Baseline up to Week 16]
Number of participants withdrawn from the study due to inadequate efficacy is reported.
- Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 [Baseline, Weeks 9 and 13]
The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). Higher score indicated a better health state. Baseline is defined as the last non-missing value prior to the first dose administration.
- Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 [Baseline, Weeks 9 and 13]
FACT-An is composed of 27 core items which assess participant's function in 4 domains and 20 anemia-related items, grouped into 5 subscales as follows: Physical well-being (PWB): 7 items; Social/family well-being (SWB): 7 items; Emotional well-being (EWB): 6 items; Functional well-being (FWB): 7 items; and Anemia: 20 items. All FACT-An items were rated as: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much. Each subscale score was the sum of scores for the items in the subscale. The FACT-An total score was the sum of all 5 subscale scores, ranging from 0 (worst) - 188 (best). Higher scores represented better quality of life. Baseline is defined as the last non-missing value prior to the first dose administration.
- Number of Participants With Potentially Clinically Significant Laboratory Tests [Baseline up to Week 16]
Criteria for the potential clinical significance included: bilirubin (µmol/L) >1.5 * upper limit of normal (ULN), potassium (mmol/L) >1.2 * ULN, neutrophils (*10^9/L) ≤1, protein (g/L) >1.1 * ULN, leukocytes (*10^9/L) ≤2.5 or ≥15.
- Number of Participants With TEAEs [Baseline up to Week 16]
An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. A summary of other nonserious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Receiving HD or PD for native kidney end-stage renal disease (ESRD) for 2 weeks to 4 months, prior to randomization
-
Mean of the 2 most recent Hb values during the screening period, obtained at least 7 days apart, must be <10.0 grams (g)/deciliter (dL), with a difference of ≤1.0 g/dL between the 2 values
-
Body weight 40 to 140 kilograms (kg)
Exclusion Criteria:
-
Previously received erythropoiesis-stimulating agents
-
Received IV iron within 4 weeks of randomization
-
Received red blood cell transfusion within 8 weeks prior to randomization or anticipated need for transfusion during the treatment period
-
Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
-
History of chronic liver disease
-
Clinically significant infection
-
New York Heart Association Class III or IV congestive heart failure
-
History of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
-
Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
-
History of other blood disorders
-
Active hemolysis or diagnosis of hemolytic syndrome
-
Known bone marrow fibrosis
-
Uncontrolled or symptomatic secondary hyperparathyroidism
-
History of alcohol or drug abuse within a year prior to randomization, or anticipated inability to avoid consumption of more than 3 alcoholic beverages per day
-
History of allergy or sensitivity to oral or IV iron therapy
-
Seizure disorder or receiving anti-epilepsy medication for seizure disorder within 12 weeks prior to randomization
-
Pregnant or breast-feeding females
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northridge | California | United States | ||
| 2 | Yuba City | California | United States | ||
| 3 | Detroit | Michigan | United States | ||
| 4 | Hong Kong | Hong Kong | |||
| 5 | Moscow | Russian Federation | |||
| 6 | St. Petersburg | Russian Federation | |||
| 7 | Singapore | Singapore |
Sponsors and Collaborators
- FibroGen
- Astellas Pharma Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
FibroGen
ClinicalTrials.gov Identifier:
NCT01414075
Other Study ID Numbers:
- FGCL-4592-053
First Posted:
Aug 11, 2011
Last Update Posted:
Oct 1, 2021
Last Verified:
Sep 1, 2021
Keywords provided by FibroGen
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants on hemodialysis (HD) were randomized to one of the 3 arms A, B, or C in 1:1:1 ratio to receive roxadustat with either no, per oral (PO), or intravenous (IV) iron supplementation, respectively. Participants on peritoneal dialysis (PD) were enrolled into Arm D and received roxadustat with PO iron supplementation. |
|---|---|
| Pre-assignment Detail | Arm E was an optional, confirmatory/supplemental arm with flexible dosing and flexible iron supplementation based on the evaluation of data from the previous 4 arms. After enrollment of Arms A through C was completed, Arm E was decided to be identical to Arm A, for example, roxadustat with no iron supplementation and with the same tiered weight-based initial dosing. Hence, the data of Arms A and E were reported in a single arm. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 milligrams [mg]) based on weight and hemoglobin (Hb) level, administered orally 3 times weekly (TIW) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Period Title: Overall Study | ||||
| STARTED | 24 | 12 | 12 | 12 |
| Efficacy Evaluable (EE) Population | 23 | 12 | 10 | 10 |
| COMPLETED | 21 | 12 | 10 | 10 |
| NOT COMPLETED | 3 | 0 | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Total of all reporting groups |
| Overall Participants | 24 | 12 | 12 | 12 | 60 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
49.6
(17.7)
|
46.8
(14.6)
|
53.1
(12.6)
|
51.4
(12.4)
|
50.1
(15.0)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
9
37.5%
|
3
25%
|
7
58.3%
|
10
83.3%
|
29
48.3%
|
| Male |
15
62.5%
|
9
75%
|
5
41.7%
|
2
16.7%
|
31
51.7%
|
Outcome Measures
| Title | Maximum Change From Baseline in Hb During Weeks 3-13 |
|---|---|
| Description | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation. |
| Time Frame | Baseline, Weeks 3-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Baseline |
8.1
(0.2)
|
8.5
(0.3)
|
8.4
(0.3)
|
8.7
(0.2)
|
| Change at Weeks 3-13 |
2.8
(0.2)
|
3.5
(0.5)
|
3.5
(0.4)
|
3.3
(0.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A + E (Participants on HD): Roxadustat Only, No Iron, Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|
| Comments | Analysis of covariance (ANCOVA) model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0757 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm A + E (Participants on HD): Roxadustat Only, No Iron, Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|---|---|---|
| Comments | ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0630 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg, Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|---|---|---|
| Comments | ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8653 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg, Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|
| Comments | ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8982 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | ANCOVA | |
| Comments | ||
| Title | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 |
|---|---|
| Description | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Time Frame | Baseline, Weeks 2-5, 6-9, and 10-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Baseline |
8.1
(0.2)
|
8.5
(0.3)
|
8.4
(0.3)
|
8.7
(0.2)
|
| Change at Weeks 2-5 |
1.1
(0.1)
|
1.1
(0.2)
|
1.0
(0.2)
|
0.8
(0.3)
|
| Change at Weeks 6-9 |
2.0
(0.2)
|
2.3
(0.4)
|
2.0
(0.4)
|
1.8
(0.4)
|
| Change at Weeks 10-13 |
2.1
(0.2)
|
2.7
(0.5)
|
3.0
(0.4)
|
2.4
(0.2)
|
| Title | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL |
|---|---|
| Description | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Time Frame | Week 3 to 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Count of Participants [Participants] |
10
41.7%
|
8
66.7%
|
8
66.7%
|
9
75%
|
| Title | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL |
|---|---|
| Description | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Time Frame | Week 3 to 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Count of Participants [Participants] |
17
70.8%
|
10
83.3%
|
8
66.7%
|
10
83.3%
|
| Title | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 |
|---|---|
| Description | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Time Frame | Weeks 5, 9, and 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Week 5 |
21
87.5%
|
9
75%
|
7
58.3%
|
7
58.3%
|
| Week 9 |
22
91.7%
|
10
83.3%
|
9
75%
|
9
75%
|
| Week 13 |
22
91.7%
|
11
91.7%
|
10
83.3%
|
10
83.3%
|
| Title | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 |
|---|---|
| Description | |
| Time Frame | Weeks 3-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| <10 g/dL |
6
25%
|
1
8.3%
|
2
16.7%
|
0
0%
|
| 10 to <11 g/dL |
7
29.2%
|
3
25%
|
0
0%
|
1
8.3%
|
| 11 to 13 g/dL |
10
41.7%
|
5
41.7%
|
5
41.7%
|
9
75%
|
| >13 to 14 g/dL |
0
0%
|
1
8.3%
|
3
25%
|
0
0%
|
| >14 g/dL |
0
0%
|
2
16.7%
|
0
0%
|
0
0%
|
| Title | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 |
|---|---|
| Description | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: <1 g/dL, ≥1 g/dL, 1 to <2 g/dL, 2 to <3 g/dL, >3 to <4 g/dL, ≥4 g/dL. |
| Time Frame | Baseline, Weeks 3-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| <1 g/dL |
1
4.2%
|
1
8.3%
|
0
0%
|
0
0%
|
| ≥1 g/dL |
22
91.7%
|
11
91.7%
|
10
83.3%
|
10
83.3%
|
| 1 to <2 g/dL |
4
16.7%
|
2
16.7%
|
2
16.7%
|
0
0%
|
| 2 to <3 g/dL |
9
37.5%
|
2
16.7%
|
0
0%
|
5
41.7%
|
| >3 to <4 g/dL |
7
29.2%
|
2
16.7%
|
4
33.3%
|
3
25%
|
| ≥4 g/dL |
2
8.3%
|
5
41.7%
|
4
33.3%
|
2
16.7%
|
| Title | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) |
|---|---|
| Description | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Time Frame | Baseline up to Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Median (95% Confidence Interval) [weeks] |
4.0
|
4.0
|
4.0
|
4.0
|
| Title | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) |
|---|---|
| Description | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Time Frame | Baseline up to Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 22 | 11 | 10 | 10 |
| Mean (Standard Deviation) [mg/kg] |
4.2
(0.5)
|
4.2
(1.2)
|
4.5
(1.4)
|
4.3
(1.4)
|
| Title | Number of Participants Requiring Dose Increase at Weeks 5 and 9 |
|---|---|
| Description | Number of participants requiring dose increase due to any reasons is reported. |
| Time Frame | Weeks 5 and 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any dose of study drug. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 24 | 12 | 12 | 12 |
| Week 5 |
2
8.3%
|
3
25%
|
2
16.7%
|
4
33.3%
|
| Week 9 |
8
33.3%
|
5
41.7%
|
3
25%
|
5
41.7%
|
| Title | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis |
|---|---|
| Description | Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported. |
| Time Frame | Weeks 5 and 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any dose of study drug. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 24 | 12 | 12 | 12 |
| Dose reduced at Week 5 |
3
12.5%
|
5
41.7%
|
3
25%
|
5
41.7%
|
| Dose interrupted at Week 5 |
1
4.2%
|
0
0%
|
0
0%
|
0
0%
|
| Dose reduced at Week 9 |
1
4.2%
|
0
0%
|
3
25%
|
0
0%
|
| Dose interrupted at Week 9 |
1
4.2%
|
0
0%
|
0
0%
|
1
8.3%
|
| Title | Change From Baseline in Ferritin at Week 13 |
|---|---|
| Description | Baseline was defined as the average of the last 2 values prior to the first dose administration. |
| Time Frame | Baseline, Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Baseline |
156.4
(12.9)
|
162.5
(30.8)
|
182.0
(27.4)
|
137.4
(27.0)
|
| Change at Week 13 |
-119.7
(12.2)
|
-51.1
(25.2)
|
-25.2
(33.5)
|
-65.1
(29.4)
|
| Title | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Baseline |
18.8
(0.8)
|
19.0
(1.0)
|
18.1
(1.5)
|
19.3
(1.8)
|
| Change at Week 13 |
-7.4
(1.4)
|
2.6
(2.5)
|
0.7
(2.9)
|
-1.6
(2.6)
|
| Title | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 21 | 10 | 10 | 10 |
| Baseline |
31.0
(0.3)
|
31.6
(0.5)
|
31.5
(0.5)
|
30.4
(0.4)
|
| Change at Week 13 |
-2.2
(0.7)
|
-1.9
(0.9)
|
-1.0
(0.6)
|
-0.2
(0.6)
|
| Title | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 |
|---|---|
| Description | |
| Time Frame | Weeks 6-9 and 10-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Weeks 6-9 |
6
25%
|
5
41.7%
|
4
33.3%
|
5
41.7%
|
| Weeks 10-13 |
5
20.8%
|
2
16.7%
|
5
41.7%
|
7
58.3%
|
| Title | Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL |
|---|---|
| Description | |
| Time Frame | Weeks 10-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants with maximum Hb ≥11 g/dL and change of Hb ≥1 g/dL during Weeks 10-13. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 10 | 8 | 8 | 9 |
| Count of Participants [Participants] |
5
20.8%
|
2
16.7%
|
5
41.7%
|
7
58.3%
|
| Title | Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL |
|---|---|
| Description | |
| Time Frame | Weeks 10-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants with maximum Hb ≥10 g/dL and change of Hb ≥1 g/dL during Weeks 10-13. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 17 | 10 | 8 | 10 |
| Count of Participants [Participants] |
15
62.5%
|
7
58.3%
|
7
58.3%
|
9
75%
|
| Title | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 |
|---|---|
| Description | |
| Time Frame | Weeks 6-9 and 10-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Week 6-9 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 10-13 |
0
0%
|
1
8.3%
|
1
8.3%
|
0
0%
|
| Title | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 |
|---|---|
| Description | |
| Time Frame | Weeks 6-9 and 10-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Week 6-9 |
10
41.7%
|
4
33.3%
|
2
16.7%
|
3
25%
|
| Week 10-13 |
8
33.3%
|
3
25%
|
2
16.7%
|
1
8.3%
|
| Title | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) |
|---|---|
| Description | Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported. |
| Time Frame | Baseline up to Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any dose of study drug. Here 'Number analyzed' signifies participants evaluable for specified category. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 24 | 12 | 12 | 12 |
| Blood transfusion for severe anemia |
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
| Blood transfusion for gastrointestinal bleeding |
1
4.2%
|
0
0%
|
0
0%
|
0
0%
|
| IV iron for acute iron deficiency |
1
4.2%
|
0
0%
|
0
0%
|
|
| IV iron for a treatment-emergent adverse event (TEAE) of thrombocytosis |
1
4.2%
|
0
0%
|
0
0%
|
| Title | Number of Participants Requiring Therapeutic Phlebotomy |
|---|---|
| Description | Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported. |
| Time Frame | Baseline up to Week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any dose of study drug. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 24 | 12 | 12 | 12 |
| Count of Participants [Participants] |
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
| Title | Number of Participants Withdrawn From the Study Due to Inadequate Efficacy |
|---|---|
| Description | Number of participants withdrawn from the study due to inadequate efficacy is reported. |
| Time Frame | Baseline up to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any dose of study drug. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 24 | 12 | 12 | 12 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 |
|---|---|
| Description | The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). Higher score indicated a better health state. Baseline is defined as the last non-missing value prior to the first dose administration. |
| Time Frame | Baseline, Weeks 9 and 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Physical functioning subscore: Baseline |
38.8
(2.3)
|
40.7
(3.2)
|
41.2
(3.4)
|
40.8
(1.8)
|
| Physical functioning subscore: Change at Week 9 |
4.8
(1.6)
|
1.6
(2.5)
|
1.5
(2.5)
|
3.4
(1.2)
|
| Physical functioning subscore: Change at Week 13 |
5.2
(1.8)
|
1.8
(2.1)
|
4.8
(1.8)
|
2.3
(1.3)
|
| Vitality subscore: Baseline |
46.3
(2.2)
|
48.2
(4.1)
|
49.0
(3.5)
|
46.8
(3.6)
|
| Vitality subscore: Change at Week 9 |
2.9
(1.8)
|
-1.0
(4.0)
|
3.4
(2.8)
|
5.9
(3.0)
|
| Vitality subscore: Change at Week 13 |
3.9
(1.7)
|
1.6
(3.7)
|
3.1
(2.3)
|
6.2
(1.6)
|
| Title | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 |
|---|---|
| Description | FACT-An is composed of 27 core items which assess participant's function in 4 domains and 20 anemia-related items, grouped into 5 subscales as follows: Physical well-being (PWB): 7 items; Social/family well-being (SWB): 7 items; Emotional well-being (EWB): 6 items; Functional well-being (FWB): 7 items; and Anemia: 20 items. All FACT-An items were rated as: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much. Each subscale score was the sum of scores for the items in the subscale. The FACT-An total score was the sum of all 5 subscale scores, ranging from 0 (worst) - 188 (best). Higher scores represented better quality of life. Baseline is defined as the last non-missing value prior to the first dose administration. |
| Time Frame | Baseline, Weeks 9 and 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 23 | 12 | 10 | 10 |
| Baseline |
123.5
(6.8)
|
118.9
(10.9)
|
128.8
(11.3)
|
122.8
(7.9)
|
| Change at Week 9 |
8.2
(4.5)
|
4.0
(7.2)
|
1.9
(9.8)
|
12.8
(6.9)
|
| Change at Week 13 |
7.3
(4.3)
|
5.9
(6.9)
|
5.1
(8.9)
|
12.9
(7.4)
|
| Title | Number of Participants With Potentially Clinically Significant Laboratory Tests |
|---|---|
| Description | Criteria for the potential clinical significance included: bilirubin (µmol/L) >1.5 * upper limit of normal (ULN), potassium (mmol/L) >1.2 * ULN, neutrophils (*10^9/L) ≤1, protein (g/L) >1.1 * ULN, leukocytes (*10^9/L) ≤2.5 or ≥15. |
| Time Frame | Baseline up to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any dose of study drug. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 24 | 12 | 12 | 12 |
| Bilirubin |
1
4.2%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium |
2
8.3%
|
1
8.3%
|
0
0%
|
1
8.3%
|
| Neutrophils |
0
0%
|
1
8.3%
|
1
8.3%
|
0
0%
|
| Protein |
1
4.2%
|
0
0%
|
0
0%
|
0
0%
|
| Leukocytes |
1
4.2%
|
0
0%
|
1
8.3%
|
0
0%
|
| Title | Number of Participants With TEAEs |
|---|---|
| Description | An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. A summary of other nonserious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Time Frame | Baseline up to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any dose of study drug. |
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Measure Participants | 24 | 12 | 12 | 12 |
| Count of Participants [Participants] |
16
66.7%
|
6
50%
|
3
25%
|
5
41.7%
|
Adverse Events
| Time Frame | Baseline up to Week 16 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events". | |||||||
| Arm/Group Title | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | ||||
| Arm/Group Description | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. | Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | ||||
All Cause Mortality |
||||||||
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/24 (12.5%) | 1/12 (8.3%) | 0/12 (0%) | 3/12 (25%) | ||||
| Cardiac disorders | ||||||||
| Cardiac failure acute | 0/24 (0%) | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Cardiac failure chronic | 1/24 (4.2%) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | ||||
| Myocardial infarction | 1/24 (4.2%) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Gastrointestinal haemorrhage | 1/24 (4.2%) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | ||||
| Infections and infestations | ||||||||
| Device related infection | 0/24 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Pyelonephritis chronic | 1/24 (4.2%) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Arteriovenous fistula thrombosis | 1/24 (4.2%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Chemical peritonitis | 0/24 (0%) | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/24 (25%) | 4/12 (33.3%) | 0/12 (0%) | 2/12 (16.7%) | ||||
| Investigations | ||||||||
| Transferrin saturation decreased | 3/24 (12.5%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 1/24 (4.2%) | 3/12 (25%) | 0/12 (0%) | 2/12 (16.7%) | ||||
| Phlebitis | 2/24 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Trial Information Desk |
|---|---|
| Organization | FibroGen, Inc. |
| Phone | 415-978-1441 |
Responsible Party:
FibroGen
ClinicalTrials.gov Identifier:
NCT01414075
Other Study ID Numbers:
- FGCL-4592-053
First Posted:
Aug 11, 2011
Last Update Posted:
Oct 1, 2021
Last Verified:
Sep 1, 2021