Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

• Status: Withdrawn
• Trial end date: 2018-02-12
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akebia Therapeutics
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• 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 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