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

Withdrawn before enrolling · Phase 3

Conditions studied: Anemia, Dialysis-Dependent Chronic Kidney Disease

In brief

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)

Key facts

Study ID

NCT03242967

Run by

Akebia Therapeutics

People needed

0

Starts

2017-08-01

Expected to finish

2018-02-12

Last updated by the study team

2018-11-05

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 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)

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 — Northridge, California, United States

Full record on ClinicalTrials.gov

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