Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
Sponsor
FibroGen (Industry)
Overall Status
Completed
CT.gov ID
NCT00761657
Collaborator
Astellas Pharma Inc (Industry)
117
34
9
43.6
3.4
0.1
Study Details
Study Description
Brief Summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This study in participants with CKD not requiring dialysis was conducted in 2 parts (designated Part 1 and Part 2). Part 1 evaluated roxadustat doses at 1.0 and 2.0 milligrams/kilograms (mg/kg). Part 2 evaluated roxadustat doses at 0.7, 1.5, and 2.0 mg/kg.
On 08 May 2007, the Food and Drug Administration (FDA) placed a clinical hold on the study until evaluation of a report of a death due to fulminant hepatic failure in a participant with CKD in a FibroGen-sponsored clinical trial of another hypoxia inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) (FG-2216) being investigated for treatment of anemia in participants with CKD and other diseases. The clinical hold resulted in early termination of Part 1 of the study. On 24 March 2008, the FDA lifted the clinical hold and Part 2 of this study started.
Study Design
Study Type:
Interventional
Actual Enrollment
:
117 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biologic Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects With Chronic Kidney Disease Not Requiring Dialysis
Actual Study Start Date
:
Nov 1, 2006
Actual Primary Completion Date
:
Jun 21, 2010
Actual Study Completion Date
:
Jun 21, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Roxadustat 0.7 mg/kg BIW Participants will receive roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. |
Drug: Roxadustat
Capsule
Other Names:
|
| Experimental: Roxadustat 0.7 mg/kg TIW Participants will receive roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. |
Drug: Roxadustat
Capsule
Other Names:
|
| Experimental: Roxadustat 1.0 mg/kg BIW Participants will receive roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. |
Drug: Roxadustat
Capsule
Other Names:
|
| Experimental: Roxadustat 1.0 mg/kg TIW Participants will receive roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. |
Drug: Roxadustat
Capsule
Other Names:
|
| Experimental: Roxadustat 1.5 mg/kg BIW Participants will receive roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. |
Drug: Roxadustat
Capsule
Other Names:
|
| Experimental: Roxadustat 1.5 mg/kg TIW Participants will receive roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. |
Drug: Roxadustat
Capsule
Other Names:
|
| Experimental: Roxadustat 2.0 mg/kg BIW Participants will receive roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. |
Drug: Roxadustat
Capsule
Other Names:
|
| Experimental: Roxadustat 2.0 mg/kg TIW Participants will receive roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. |
Drug: Roxadustat
Capsule
Other Names:
|
| Placebo Comparator: Placebo Participants will receive placebo orally, matching to the roxadustat dose, number of days per week, and duration. |
Drug: Placebo
Capsule
|
Outcome Measures
Primary Outcome Measures
- Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) [Baseline up to Week 16 (End of Study (EoS])]
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 defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or definite relationship to study drug. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
- Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) [Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)]
Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline was defined as the mean of last 3 available values prior to the first dose.
- Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) [Baseline, Week 8 (2 Weeks of Follow Up)]
Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline is defined as the mean of last 3 available values prior to the first dose.
Secondary Outcome Measures
- Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) [Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up)]
Hb response defined as an increase in Hb from baseline by ≥1.0 g/dL (not due to red blood cell transfusion or IV iron supplementation during treatment). The baseline for Hb was defined as the mean of the last 3 available Hb values obtained prior to the first dose.
- Plasma Roxadustat Concentration (Part 2) [Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups)]
- Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 [Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing)]
Baseline is defined as the last value obtained prior to the first dose.
- Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 [Baseline, 4, 8, 12, and 24 hours on Day 1]
Baseline is defined as the last value obtained prior to the first dose.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader.
-
Chronic Kidney Disease Stage 3 or 4 with hemoglobin <11.0 grams (g)/deciliter (dL).
-
Normal iron studies.
-
Normal folate and vitamin B12 levels.
-
Liver function tests within normal limits at screening.
-
Absence of active or chronic rectal bleeding.
-
Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema, or diabetic proliferative retinopathy that is likely to require treatment during the trial.
-
Female participants must not be pregnant nor breastfeeding and agree to use acceptable method of contraception.
-
Male participants with partners who can have children must agree to use a medically acceptable method of contraception.
Exclusion Criteria:
-
Seropositive for HIV.
-
History of chronic liver disease.
-
History of polycystic kidney disease (PKD).
-
Uncontrolled hypertension (diastolic BP >110 millimeter of mercury (mmHg) or systolic BP >170 mmHg at screening).
-
New York Heart Association Class III or IV congestive heart failure.
-
Recent myocardial infarction or acute coronary syndrome.
-
History of myelodysplastic syndrome.
-
Any history of malignancy or a known genetic predisposition for developing cancer (for example, with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.
-
Active inflammatory infection or chronic inflammatory disease.
-
Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
-
Blood clots within 4 weeks.
-
History of ongoing hemolysis or diagnosis of hemolytic syndrome.
-
Known history of bone marrow fibrosis.
-
History of hemosiderosis or hemochromatosis.
-
Androgen therapy within 12 weeks.
-
Red blood cell transfusion within 12 weeks.
-
Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
-
Intravenous iron supplementation within the past 60 days.
-
Currently taking dapsone or acetaminophen >2.6 g/day.
-
History of prior organ transplantation.
-
Alcohol consumption greater than 3 or more drinks per day within the past year.
-
Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
-
Positive urine toxicology screen for a substance that has not been prescribed for the participant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peoria | Arizona | United States | 85381 | |
| 2 | Tempe | Arizona | United States | 85284 | |
| 3 | Los Angeles | California | United States | 90095 | |
| 4 | Mission Viejo | California | United States | 92691 | |
| 5 | Sacramento | California | United States | 95825 | |
| 6 | San Diego | California | United States | 92123 | |
| 7 | Whittier | California | United States | 90603 | |
| 8 | Arvada | Colorado | United States | 80002 | |
| 9 | Westminster | Colorado | United States | 80031 | |
| 10 | Middlebury | Connecticut | United States | 06762 | |
| 11 | Ocala | Florida | United States | 34471 | |
| 12 | Panama City | Florida | United States | 32401 | |
| 13 | Pembroke Pines | Florida | United States | 33028 | |
| 14 | Tampa | Florida | United States | 33614 | |
| 15 | Augusta | Georgia | United States | 30901 | |
| 16 | Chicago | Illinois | United States | 60616 | |
| 17 | Evergreen Park | Illinois | United States | 60805 | |
| 18 | Wichita | Kansas | United States | 67214 | |
| 19 | Louisville | Kentucky | United States | 40202 | |
| 20 | Baton Rouge | Louisiana | United States | 70809 | |
| 21 | Shreveport | Louisiana | United States | 71101 | |
| 22 | Detroit | Michigan | United States | 48236 | |
| 23 | Lincoln | Nebraska | United States | 68510 | |
| 24 | Las Vegas | Nevada | United States | 89106 | |
| 25 | Flushing | New York | United States | 11355 | |
| 26 | Winston-Salem | North Carolina | United States | 27103 | |
| 27 | Cleveland | Ohio | United States | 44109 | |
| 28 | Toledo | Ohio | United States | 43606 | |
| 29 | Medford | Oregon | United States | 97504 | |
| 30 | Wynnewood | Pennsylvania | United States | 19096 | |
| 31 | Columbia | South Carolina | United States | 29203 | |
| 32 | Orangeburg | South Carolina | United States | 29118 | |
| 33 | Chattanooga | Tennessee | United States | 37404 | |
| 34 | Houston | Texas | United States | 77036 |
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:
NCT00761657
Other Study ID Numbers:
- FGCL-SM4592-017
First Posted:
Sep 29, 2008
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Keywords provided by FibroGen
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | On 08 May 2007, the Food and Drug Administration (FDA) placed a clinical hold on the study. The clinical hold resulted in early termination of Part 1 of the study. On 24 March 2008, the FDA lifted the clinical hold and Part 2 of this study started. |
| Arm/Group Title | Roxadustat 0.7 Milligrams/Kilograms (mg/kg) BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. | Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. | Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. |
| Period Title: Part 1 (up to Day 57) | |||||||||
| STARTED | 0 | 0 | 12 | 10 | 0 | 0 | 1 | 2 | 10 |
| Safety Population | 0 | 0 | 12 | 9 | 0 | 0 | 1 | 2 | 10 |
| Efficacy Evaluable (EE) Population | 0 | 0 | 5 | 5 | 0 | 0 | 0 | 1 | 6 |
| Pharmacokinetic (PK) Population | 0 | 0 | 5 | 3 | 0 | 0 | 1 | 2 | 0 |
| COMPLETED | 0 | 0 | 8 | 4 | 0 | 0 | 0 | 1 | 9 |
| NOT COMPLETED | 0 | 0 | 4 | 6 | 0 | 0 | 1 | 1 | 1 |
| Period Title: Part 1 (up to Day 57) | |||||||||
| STARTED | 10 | 13 | 0 | 0 | 10 | 11 | 10 | 10 | 18 |
| Safety Population | 10 | 13 | 0 | 0 | 10 | 11 | 10 | 10 | 18 |
| EE Population | 10 | 12 | 0 | 0 | 10 | 11 | 10 | 10 | 11 |
| PK Population | 10 | 13 | 0 | 0 | 10 | 11 | 10 | 10 | 0 |
| COMPLETED | 10 | 13 | 0 | 0 | 10 | 11 | 10 | 10 | 17 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. | Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. | Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. | Total of all reporting groups |
| Overall Participants | 10 | 13 | 12 | 9 | 10 | 11 | 11 | 12 | 28 | 116 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [years] |
64.6
(4.9)
|
60.6
(9.2)
|
69.5
(7.7)
|
67.0
(8.4)
|
63.8
(8.8)
|
63.5
(6.4)
|
64.3
(9.0)
|
66.8
(7.8)
|
68.6
(6.2)
|
65.8
(7.8)
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
4
40%
|
7
53.8%
|
8
66.7%
|
3
33.3%
|
6
60%
|
10
90.9%
|
8
72.7%
|
9
75%
|
12
42.9%
|
67
57.8%
|
| Male |
6
60%
|
6
46.2%
|
4
33.3%
|
6
66.7%
|
4
40%
|
1
9.1%
|
3
27.3%
|
3
25%
|
16
57.1%
|
49
42.2%
|
Outcome Measures
| Title | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) |
|---|---|
| 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 defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or definite relationship to study drug. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Time Frame | Baseline up to Week 16 (End of Study (EoS]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug. |
| Arm/Group Title | Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. | Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. | Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. |
| Measure Participants | 10 | 13 | 12 | 9 | 10 | 11 | 11 | 12 | 28 |
| Any TEAEs |
3
30%
|
9
69.2%
|
7
58.3%
|
5
55.6%
|
9
90%
|
7
63.6%
|
7
63.6%
|
5
41.7%
|
13
46.4%
|
| Serious TEAEs |
0
0%
|
4
30.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.6%
|
| Severe TEAEs |
0
0%
|
3
23.1%
|
1
8.3%
|
0
0%
|
0
0%
|
1
9.1%
|
1
9.1%
|
0
0%
|
1
3.6%
|
| Drug-Related TEAEs |
1
10%
|
2
15.4%
|
2
16.7%
|
1
11.1%
|
3
30%
|
3
27.3%
|
3
27.3%
|
1
8.3%
|
3
10.7%
|
| TEAEs Leading to Treatment Discontinuation |
0
0%
|
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
1
9.1%
|
0
0%
|
1
3.6%
|
| Title | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) |
|---|---|
| Description | Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline was defined as the mean of last 3 available values prior to the first dose. |
| Time Frame | Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL and were in study treatment for at least 2.5 weeks with corresponding Hb values. Last-observation-carried-forward (LOCF) method was used to impute missing values. |
| Arm/Group Title | Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. | Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. | Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. |
| Measure Participants | 10 | 12 | 5 | 5 | 10 | 11 | 9 | 11 | 23 |
| Baseline |
10.32
(0.678)
|
10.03
(0.709)
|
9.18
(0.600)
|
10.35
(0.849)
|
10.28
(0.551)
|
10.08
(0.650)
|
9.97
(0.430)
|
9.93
(0.806)
|
10.10
(0.616)
|
| Change at Day 26-29 |
0.25
(0.849)
|
0.60
(0.756)
|
0.44
(0.781)
|
0.21
(1.016)
|
1.22
(1.112)
|
1.65
(1.033)
|
1.35
(0.577)
|
1.75
(1.200)
|
-0.05
(0.500)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 0.7 mg/kg BIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2073 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 0.7 mg/kg TIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0046 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 1.0 mg/kg BIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0860 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 1.0 mg/kg TIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4005 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 1.5 mg/kg BIW, Placebo |
|---|---|---|
| Comments | P-value is presented for Day 26-29 timepoint. P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 1.5 mg/kg TIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 2.0 mg/kg BIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 2.0 mg/kg TIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | Threshold for significance at 0.05 level. | |
| Title | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) |
|---|---|
| Description | Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline is defined as the mean of last 3 available values prior to the first dose. |
| Time Frame | Baseline, Week 8 (2 Weeks of Follow Up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL and were in study treatment for at least 2.5 weeks with corresponding Hb values. LOCF method was used to impute missing values. |
| Arm/Group Title | Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. | Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. | Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. |
| Measure Participants | 10 | 12 | 5 | 5 | 10 | 11 | 9 | 11 | 23 |
| Baseline |
10.32
(0.678)
|
10.03
(0.709)
|
9.18
(0.600)
|
10.35
(0.849)
|
10.28
(0.551)
|
10.08
(0.650)
|
9.97
(0.430)
|
9.93
(0.806)
|
10.10
(0.616)
|
| Change at Week 8 |
0.59
(0.808)
|
0.24
(0.846)
|
0.50
(0.356)
|
0.05
(1.435)
|
0.79
(0.916)
|
1.31
(0.743)
|
1.21
(0.656)
|
1.52
(0.815)
|
0.04
(0.684)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 0.7 mg/kg BIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0507 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 0.7 mg/kg TIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4502 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 1.0 mg/kg BIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | Threshold for significance at 0.05 level. | |
| Statistical Test of Hypothesis | p-Value | 0.1603 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 1.0 mg/kg TIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9816 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 1.5 mg/kg BIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0139 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 1.5 mg/kg TIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 2.0 mg/kg BIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Roxadustat 2.0 mg/kg TIW, Placebo |
|---|---|---|
| Comments | P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Threshold for significance at 0.05 level. | |
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) |
|---|---|
| Description | Hb response defined as an increase in Hb from baseline by ≥1.0 g/dL (not due to red blood cell transfusion or IV iron supplementation during treatment). The baseline for Hb was defined as the mean of the last 3 available Hb values obtained prior to the first dose. |
| Time Frame | Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL) and were in study treatment for at least 2.5 weeks with corresponding Hb values. |
| Arm/Group Title | Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. | Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. | Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. |
| Measure Participants | 10 | 12 | 5 | 5 | 10 | 11 | 9 | 11 | 23 |
| Day 26-29 |
1
10%
|
6
46.2%
|
1
8.3%
|
1
11.1%
|
8
80%
|
10
90.9%
|
7
63.6%
|
9
75%
|
3
10.7%
|
| Week 8 |
5
50%
|
7
53.8%
|
3
25%
|
2
22.2%
|
8
80%
|
10
90.9%
|
9
81.8%
|
11
91.7%
|
6
21.4%
|
| Week 16 |
7
70%
|
7
53.8%
|
3
25%
|
2
22.2%
|
9
90%
|
10
90.9%
|
9
81.8%
|
11
91.7%
|
8
28.6%
|
| Title | Plasma Roxadustat Concentration (Part 2) |
|---|---|
| Description | |
| Time Frame | Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 2 PK Population: Participants who received roxadustat and had sufficient plasma data to allow calculation of PK parameters. Participants in the roxadustat groups were evaluated. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. |
| Measure Participants | 10 | 13 | 10 | 11 | 9 | 10 |
| Day 3 |
394.800
(723.156)
|
260.027
(133.524)
|
422.700
(148.529)
|
|||
| Day 4 |
28.596
(19.737)
|
168.310
(174.426)
|
283.067
(376.601)
|
|||
| Day 8 |
19.884
(18.858)
|
203.535
(343.167)
|
125.185
(223.124)
|
168.955
(147.019)
|
291.856
(376.910)
|
297.500
(393.134)
|
| Day 15 |
22.997
(18.442)
|
195.483
(369.794)
|
134.116
(269.890)
|
247.945
(204.624)
|
358.400
(491.898)
|
175.570
(144.779)
|
| Day 22 |
36.432
(33.587)
|
153.903
(173.388)
|
147.323
(235.302)
|
163.100
(167.695)
|
171.833
(138.575)
|
239.600
(324.307)
|
| Day 26 |
331.640
(435.773)
|
223.140
(140.340)
|
508.889
(295.228)
|
|||
| Day 29 |
14.332
(9.935)
|
150.599
(233.871)
|
193.622
(279.533)
|
| Title | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 |
|---|---|
| Description | Baseline is defined as the last value obtained prior to the first dose. |
| Time Frame | Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 Safety Population: Participants who received at least 1 dose of study drug. Participants with missing erythropoietin values at any timepoint were excluded from analysis. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. | Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. |
| Measure Participants | 5 | 3 | 1 | 2 | 6 |
| Day 1, Baseline |
13.46
(5.69)
|
13.30
(6.59)
|
9.00
(NA)
|
8.50
(3.96)
|
13.75
(4.53)
|
| Change at Day 26, 1 Hour |
-1.50
(1.41)
|
0.00
(NA)
|
0.17
(0.21)
|
||
| Change at Day 26, 2 Hour |
-0.85
(1.91)
|
-0.60
(NA)
|
0.67
(1.47)
|
||
| Change at Day 26, 3 Hour |
-0.95
(1.34)
|
2.30
(NA)
|
-1.27
(3.15)
|
||
| Change at Day 26, 4 Hour |
-0.45
(0.07)
|
29.70
(NA)
|
0.50
(4.24)
|
||
| Change at Day 26, 6 Hour |
8.05
(11.81)
|
132.80
(NA)
|
0.33
(3.80)
|
||
| Change at Day 26, 8 Hour |
57.95
(63.29)
|
462.00
(NA)
|
0.20
(1.18)
|
||
| Change at Day 26, 12 Hour |
81.80
(81.03)
|
492.00
(NA)
|
-1.30
(1.71)
|
||
| Change at Day 26, 18 Hour |
37.30
(13.01)
|
176.90
(NA)
|
0.87
(1.07)
|
||
| Change at Day 26, 24 Hour |
22.35
(19.73)
|
33.90
(NA)
|
2.60
(5.46)
|
||
| Change at Day 26, 48 Hour |
0.55
(10.39)
|
-0.50
(NA)
|
-7.50
(2.40)
|
||
| Change at Day 26, 72 Hour |
-2.85
(5.02)
|
-1.50
(NA)
|
-0.60
(1.27)
|
||
| Change at Day 29, 1 Hour |
-1.08
(1.22)
|
-1.57
(1.14)
|
|||
| Change at Day 29, 2 Hour |
-1.27
(2.23)
|
-2.73
(1.85)
|
|||
| Change at Day 29, 3 Hour |
-0.55
(1.13)
|
-3.70
(2.14)
|
|||
| Change at Day 29, 4 Hour |
12.03
(10.12)
|
-4.90
(1.95)
|
|||
| Change at Day 29, 6 Hour |
66.85
(43.07)
|
-4.17
(1.27)
|
|||
| Change at Day 29, 8 Hour |
135.08
(83.95)
|
-2.97
(2.20)
|
|||
| Change at Day 29, 12 Hour |
77.35
(43.80)
|
-2.07
(1.08)
|
|||
| Change at Day 29, 18 Hour |
43.80
(13.41)
|
-0.20
(1.77)
|
|||
| Change at Day 29, 24 Hour |
10.18
(3.16)
|
-3.07
(0.96)
|
|||
| Change at Day 29, 48 Hour |
-5.17
(4.70)
|
-4.87
(2.24)
|
|||
| Change at Day 29, 72 Hour |
-2.93
(3.91)
|
-1.63
(4.71)
|
| Title | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 |
|---|---|
| Description | Baseline is defined as the last value obtained prior to the first dose. |
| Time Frame | Baseline, 4, 8, 12, and 24 hours on Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 2 PK Population: Participants who received roxadustat and had sufficient plasma data to allow calculation of PK parameters. Participants with missing erythropoietin values at any timepoint were excluded from analysis. |
| Arm/Group Title | Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. |
| Measure Participants | 0 | 2 | 2 | 0 | 2 | 0 | 0 |
| Baseline |
8.30
(2.26)
|
9.55
(3.32)
|
10.45
(4.31)
|
||||
| Change at 4 Hour |
2.80
(3.96)
|
2.10
(3.54)
|
1.00
(2.97)
|
||||
| Change at 8 Hour |
66.70
(90.23)
|
100.40
(92.77)
|
42.05
(36.98)
|
||||
| Change at 12 Hour |
66.25
(90.16)
|
147.15
(128.91)
|
201.10
(240.42)
|
||||
| Change at 24 Hour |
10.05
(8.56)
|
107.65
(53.25)
|
461.05
(589.80)
|
Adverse Events
| Time Frame | Baseline up to Week 16 (EoS) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug. | |||||||||||||||||
| Arm/Group Title | Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo | |||||||||
| Arm/Group Description | Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. | Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. | Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. | |||||||||
All Cause Mortality |
||||||||||||||||||
| Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 4/13 (30.8%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 1/28 (3.6%) | |||||||||
| Cardiac disorders | ||||||||||||||||||
| Pericarditis | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 1/28 (3.6%) | |||||||||
| General disorders | ||||||||||||||||||
| Non-cardiac chest pain | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Arteriovenous fistula site | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Femoral neck fracture | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Renal and urinary disorders | ||||||||||||||||||
| Renal failure acute | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 1/28 (3.6%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Dyspnoea | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/10 (30%) | 9/13 (69.2%) | 7/12 (58.3%) | 5/9 (55.6%) | 9/10 (90%) | 7/11 (63.6%) | 7/11 (63.6%) | 5/12 (41.7%) | 12/28 (42.9%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Anaemia | 1/10 (10%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Cardiac disorders | ||||||||||||||||||
| Sinus bradycardia | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 2/28 (7.1%) | |||||||||
| Bradycardia | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Cardiac failure congestive | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Ventricular extrasystoles | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Ear and labyrinth disorders | ||||||||||||||||||
| Ear pain | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Endocrine disorders | ||||||||||||||||||
| Hyperparathyroidism secondary | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Hypothyroidism | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Eye disorders | ||||||||||||||||||
| Diabetic retinopathy | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Eyelid oedema | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 1/12 (8.3%) | 0/28 (0%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Diarrhoea | 0/10 (0%) | 3/13 (23.1%) | 2/12 (16.7%) | 1/9 (11.1%) | 1/10 (10%) | 0/11 (0%) | 1/11 (9.1%) | 0/12 (0%) | 2/28 (7.1%) | |||||||||
| Constipation | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 1/28 (3.6%) | |||||||||
| Gastrooesophageal reflux disease | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/12 (8.3%) | 0/28 (0%) | |||||||||
| Nausea | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 1/9 (11.1%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 1/28 (3.6%) | |||||||||
| Abdominal pain | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Abdominal pain upper | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Ascites | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Dyspepsia | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Gastritis | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Gastrointestinal disorder | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 1/9 (11.1%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Lip swelling | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| General disorders | ||||||||||||||||||
| Fatigue | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 1/9 (11.1%) | 0/10 (0%) | 0/11 (0%) | 2/11 (18.2%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Oedema peripheral | 0/10 (0%) | 1/13 (7.7%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Chills | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Oedema | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Pyrexia | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Non-cardiac chest pain | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Hepatobiliary disorders | ||||||||||||||||||
| Gallbladder polyp | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Immune system disorders | ||||||||||||||||||
| Seasonal allergy | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 2/28 (7.1%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Urinary tract infection | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 1/9 (11.1%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 3/28 (10.7%) | |||||||||
| Influenza | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 1/12 (8.3%) | 1/28 (3.6%) | |||||||||
| Bronchitis | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Cystitis | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 1/12 (8.3%) | 0/28 (0%) | |||||||||
| Sinusitis | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Tooth abscess | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Tooth infection | 1/10 (10%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Upper respiratory tract infection | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Excoriation | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Foot fracture | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Laceration | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Procedural pain | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Skin laceration | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 1/9 (11.1%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Investigations | ||||||||||||||||||
| Alanine aminotransferase increased | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Blood uric acid increased | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Electrocardiogram poor R-wave progression | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Electrocardiogram repolarisation abnormality | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Hepatic enzyme increased | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||
| Hyperkalaemia | 1/10 (10%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 2/10 (20%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Hyperuricaemia | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 2/11 (18.2%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Acidosis | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Anorexia | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Decreased appetite | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Diabetes mellitus | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Gout | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Hyperglycaemia | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Hypernatraemia | 1/10 (10%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Hyperphosphataemia | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 1/12 (8.3%) | 0/28 (0%) | |||||||||
| Hypoglycaemia | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Metabolic acidosis | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Type 2 diabetes mellitus | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Vitamin D deficiency | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Back pain | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 2/9 (22.2%) | 1/10 (10%) | 0/11 (0%) | 1/11 (9.1%) | 0/12 (0%) | 1/28 (3.6%) | |||||||||
| Muscle spasms | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 1/28 (3.6%) | |||||||||
| Myalgia | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 1/9 (11.1%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Arthralgia | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Osteoporosis | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||
| Benign breast neoplasm | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 1/12 (8.3%) | 0/28 (0%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| Headache | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 1/9 (11.1%) | 3/10 (30%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 1/28 (3.6%) | |||||||||
| Dizziness | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 1/9 (11.1%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 2/28 (7.1%) | |||||||||
| Neuropathy peripheral | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Psychiatric disorders | ||||||||||||||||||
| Insomnia | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 1/28 (3.6%) | |||||||||
| Depression | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Renal and urinary disorders | ||||||||||||||||||
| Renal impairment | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 2/11 (18.2%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Micturition urgency | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Reproductive system and breast disorders | ||||||||||||||||||
| Breast cyst | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 1/9 (11.1%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Prostatitis | 0/6 (0%) | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/4 (0%) | 0/1 (0%) | 0/3 (0%) | 0/3 (0%) | 0/16 (0%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Allergic sinusitis | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 1/12 (8.3%) | 0/28 (0%) | |||||||||
| Cough | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Postnasal drip | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Wheezing | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Dyspnoea | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Drug eruption | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Erythema | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 1/10 (10%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Increased tendency to bruise | 1/10 (10%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Intertrigo | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Pruritus | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Rash | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Skin lesion | 0/10 (0%) | 0/13 (0%) | 1/12 (8.3%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Skin ulcer | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 1/9 (11.1%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Surgical and medical procedures | ||||||||||||||||||
| Nail operation | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Vascular disorders | ||||||||||||||||||
| Hot flush | 0/10 (0%) | 0/13 (0%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/12 (0%) | 0/28 (0%) | |||||||||
| Hypertension | 0/10 (0%) | 1/13 (7.7%) | 0/12 (0%) | 0/9 (0%) | 0/10 (0%) | 0/11 (0%) | 0/11 (0%) | 0/12 (0%) | 0/28 (0%) | |||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Clinical Trial Information Desk |
|---|---|
| Organization | FibroGen, Inc. |
| Phone | 415-978-1441 |
Responsible Party:
FibroGen
ClinicalTrials.gov Identifier:
NCT00761657
Other Study ID Numbers:
- FGCL-SM4592-017
First Posted:
Sep 29, 2008
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021