Study Stopped
Revised study design.
Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
1 other identifier
interventional
2
1 country
18
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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2017
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2017
CompletedFirst Submitted
Initial submission to the registry
May 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2018
CompletedResults Posted
Study results publicly available
February 21, 2021
CompletedFebruary 21, 2021
February 1, 2021
11 months
May 3, 2017
February 2, 2021
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period
Baseline; up to 20 weeks
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
vadadustat
EXPERIMENTALVadadustat daily oral dose, adjustable based on Hb level
epoetin alfa
ACTIVE COMPARATOREpoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Research Site
Bakersfield, California, 93309, United States
Research Site
Elk Grove, California, 95758, United States
Research Site
Encino, California, 91316, United States
Research Site
Escondido, California, 92025, United States
Research Site
Lynwood, California, 90262, United States
Research Site
San Diego, California, 92115, United States
Research Site
San Luis Obispo, California, 93401, United States
Research Site
Waterbury, Connecticut, 06708, United States
Research Site
Miami, Florida, 33183, United States
Research Site
Orlando, Florida, 32804, United States
Research Site
Statesboro, Georgia, 30458, United States
Research Site
Detroit, Michigan, 48224, United States
Research Site
The Bronx, New York, 10473, United States
Research Site
Philadelphia, Pennsylvania, 19106, United States
Research Site
El Paso, Texas, 79915, United States
Research Site
Houston, Texas, 77070, United States
Research Site
Newport News, Virginia, 23605, United States
Research Site
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The Study was closed by the Sponsor as it was determined that it was more appropriate to initiate a new study that would explore the broader population utilizing a modified dosing approach (rather than amending the current protocol design).
Results Point of Contact
- Title
- Akebia Therapeutics
- Organization
- Akebia Therapeutics
Study Officials
- STUDY DIRECTOR
Akebia Therapeutics
Sponsor GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2017
First Posted
May 4, 2017
Study Start
May 2, 2017
Primary Completion
March 21, 2018
Study Completion
March 21, 2018
Last Updated
February 21, 2021
Results First Posted
February 21, 2021
Record last verified: 2021-02