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
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:May 23, 2017
End Date:April 11, 2018

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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

This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa
for the treatment of anemia in subjects with DD-CKD who are hyporesponsive to ESAs.


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 at a dose of ≥7700 units per dialysis
treatment session or ≥23100 units per week

- 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
We found this trial at
18
sites
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Waterbury, CT
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Bakersfield, CA
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Bronx, NY
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Detroit, MI
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El Paso, TX
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Elk Grove, CA
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Encino, CA
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Escondido, CA
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Houston, TX
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Lynwood, CA
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Miami, FL
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Newport News, VA
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Norfolk, VA
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Orlando, FL
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Philadelphia, PA
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San Diego, CA
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San Luis Obispo, California 93405
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San Luis Obispo, CA
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Statesboro, GA
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