Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

• Status: Terminated
• Trial end date: 2018-03-21
• Target enrollment: 0
• Participant gender: All

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.)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akebia Therapeutics
• Treatments: Epoetin Alfa; Hematinics

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