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

Stopped early · Phase 2

Conditions studied: Anemia, Dialysis-Dependent Chronic Kidney Disease

In brief

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.)

Key facts

Study ID

NCT03140722

Run by

Akebia Therapeutics

People needed

2

Starts

2017-05-02

Expected to finish

2018-03-21

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Research Site — Bakersfield, California, United States
• Research Site — Elk Grove, California, United States
• Research Site — Encino, California, United States
• Research Site — Escondido, California, United States
• Research Site — Lynwood, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Luis Obispo, California, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Statesboro, Georgia, United States
• Research Site — Detroit, Michigan, United States
• Research Site — The Bronx, New York, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — El Paso, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Newport News, Virginia, United States
• Research Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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