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

Akebia Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Anemia; Dialysis-Dependent Chronic Kidney Disease

Treatments: Drug: epoetin alfa; Drug: vadadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03140722

AKB-6548-CI-0018

Details and patient eligibility

About

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.)

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

vadadustat

Experimental group

Description:

Vadadustat daily oral dose, adjustable based on Hb level

Treatment:

Drug: vadadustat

epoetin alfa

Active Comparator group

Description:

Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study

Treatment:

Drug: epoetin alfa