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

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

sites

Clinical Trial Facility in Waterbury Connecticut

Waterbury, Connecticut 06708

from

Waterbury, CT