Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
Study Details
Study Description
Brief Summary
This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.)
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: vadadustat Vadadustat daily oral dose, adjustable based on Hb level |
Drug: vadadustat
vadadustat
Other Names:
|
Active Comparator: epoetin alfa Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study |
Drug: epoetin alfa
epoetin alfa
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period [Baseline; up to 20 weeks]
Secondary Outcome Measures
- Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period [Baseline; up to 20 weeks]
- Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period [Baseline; up to 20 weeks]
- Number of Participants Receiving Epoetin Alfa Rescue [up to 20 weeks]
- Number of Participants Receiving Red Blood Cell Transfusion [up to 20 weeks]
- Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor [up to 20 weeks]
- Mean Weekly Dose of Intravenous Elemental Iron Administered [up to 20 weeks]
- Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%) [up to 20 weeks]
- Number of Participants Utilizing Resources [up to 20 weeks]
- Number of Participants With Treatment-emergent Adverse Events [up to 24 weeks]
Treatment-emergent adverse events were collected in all participants enrolled in the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and female subjects ≥18 years of age
-
Receiving chronic maintenance hemodialysis for end-stage kidney disease
-
Currently receiving epoetin alfa for anemia
-
Hb between 8.5 and 10.0 g/dL during screening
Exclusion Criteria:
-
Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
-
Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
-
Red blood cell transfusion within 4 weeks prior to or during screening
-
Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Site | Bakersfield | California | United States | 93309 |
2 | Research Site | Elk Grove | California | United States | 95758 |
3 | Research Site | Encino | California | United States | 91316 |
4 | Research Site | Escondido | California | United States | 92025 |
5 | Research Site | Lynwood | California | United States | 90262 |
6 | Research Site | San Diego | California | United States | 92115 |
7 | Research Site | San Luis Obispo | California | United States | 93401 |
8 | Research Site | Waterbury | Connecticut | United States | 06708 |
9 | Research Site | Miami | Florida | United States | 33183 |
10 | Research Site | Orlando | Florida | United States | 32804 |
11 | Research Site | Statesboro | Georgia | United States | 30458 |
12 | Research Site | Detroit | Michigan | United States | 48224 |
13 | Research Site | Bronx | New York | United States | 10473 |
14 | Research Site | Philadelphia | Pennsylvania | United States | 19106 |
15 | Research Site | El Paso | Texas | United States | 79915 |
16 | Research Site | Houston | Texas | United States | 77070 |
17 | Research Site | Newport News | Virginia | United States | 23605 |
18 | Research Site | Norfolk | Virginia | United States | 23502 |
Sponsors and Collaborators
- Akebia Therapeutics
Investigators
- Study Director: Akebia Therapeutics, Sponsor GmbH
Study Documents (Full-Text)
More Information
Publications
None provided.- AKB-6548-CI-0018
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Period Title: Overall Study | ||
STARTED | 0 | 2 |
COMPLETED | 0 | 2 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Vadadustat | Epoetin Alfa | Total |
---|---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. | Total of all reporting groups |
Overall Participants | 0 | 2 | 2 |
Age (Count of Participants) | |||
<=18 years |
0
NaN
|
0
0%
|
|
Between 18 and 65 years |
1
Infinity
|
1
50%
|
|
>=65 years |
1
Infinity
|
1
50%
|
|
Sex: Female, Male (Count of Participants) | |||
Female |
NA
NaN
|
NA
NaN
|
|
Male |
NA
NaN
|
NA
NaN
|
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
NA
NaN
|
NA
NaN
|
|
Asian |
NA
NaN
|
NA
NaN
|
|
Native Hawaiian or Other Pacific Islander |
NA
NaN
|
NA
NaN
|
|
Black or African American |
NA
NaN
|
NA
NaN
|
|
White |
NA
NaN
|
NA
NaN
|
|
More than one race |
NA
NaN
|
NA
NaN
|
|
Unknown or Not Reported |
NA
NaN
|
NA
NaN
|
Outcome Measures
Title | Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period |
---|---|
Description | |
Time Frame | Baseline; up to 20 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 0 |
Title | Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period |
---|---|
Description | |
Time Frame | Baseline; up to 20 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 0 |
Title | Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period |
---|---|
Description | |
Time Frame | Baseline; up to 20 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 0 |
Title | Number of Participants Receiving Epoetin Alfa Rescue |
---|---|
Description | |
Time Frame | up to 20 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 0 |
Title | Number of Participants Receiving Red Blood Cell Transfusion |
---|---|
Description | |
Time Frame | up to 20 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 0 |
Title | Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor |
---|---|
Description | |
Time Frame | up to 20 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 0 |
Title | Mean Weekly Dose of Intravenous Elemental Iron Administered |
---|---|
Description | |
Time Frame | up to 20 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 0 |
Title | Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%) |
---|---|
Description | |
Time Frame | up to 20 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 0 |
Title | Number of Participants Utilizing Resources |
---|---|
Description | |
Time Frame | up to 20 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 0 |
Title | Number of Participants With Treatment-emergent Adverse Events |
---|---|
Description | Treatment-emergent adverse events were collected in all participants enrolled in the study. |
Time Frame | up to 24 weeks |
Outcome Measure Data
Analysis Population Description |
---|
All participants enrolled in the study |
Arm/Group Title | Vadadustat | Epoetin Alfa |
---|---|---|
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. |
Measure Participants | 0 | 2 |
Count of Participants [Participants] |
0
NaN
|
0
0%
|
Adverse Events
Time Frame | up to Week 24 | |||
---|---|---|---|---|
Adverse Event Reporting Description | No participants were enrolled in the vadadustat arm of the study. | |||
Arm/Group Title | Vadadustat | Epoetin Alfa | ||
Arm/Group Description | Participants were to discontinue epoetin alfa, administered during the 28-day Screening Period, and initiate vadadustat on Day 1 of the 20-week treatment period. The vadadustat daily oral dose was adjustable based on the target hemoglobin (Hb) level of 10.0 to 11.0 grams per deciliter (g/dL). | Participants were to receive the same dose of epoetin alfa administered during the 28-day Screening Period starting on Day 1 of the 20-week Treatment Period. Epoetin alfa was administered based on the approved label for adult participants with Chronic Kidney Disease (CKD) on dialysis, and the dose was adjustable based on Hb level, as clinically indicated throughout the study. | ||
All Cause Mortality |
||||
Vadadustat | Epoetin Alfa | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/2 (0%) | ||
Serious Adverse Events |
||||
Vadadustat | Epoetin Alfa | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/2 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Vadadustat | Epoetin Alfa | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/2 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
Name/Title | Akebia Therapeutics |
---|---|
Organization | Akebia Therapeutics |
Phone | (617) 844-6128 |
trials@akebia.com |
- AKB-6548-CI-0018