Status:
WITHDRAWN
Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Lead Sponsor:
Akebia Therapeutics
Conditions:
Anemia
Dialysis-Dependent Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Eligibility Criteria
Inclusion
- Male and female subjects ≥18 years of age
- Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease
- Currently maintained on ESA therapy
- Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03242967
Start Date
August 1 2017
End Date
February 12 2018
Last Update
November 5 2018
Active Locations (1)
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1
Research Site
Northridge, California, United States, 91324