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

Phase 2TerminatedNCT03140722

Akebia Therapeutics2 enrolled

Overview

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.)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia Dialysis-Dependent Chronic Kidney Disease

Interventions

vadadustatDRUG

vadadustat

epoetin alfaDRUG

epoetin alfa

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Research Site

Bakersfield, California, United States

Research Site

Elk Grove, California, United States

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period

Time frame: Baseline; up to 20 weeks

Secondary Outcomes

Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period

Time frame: Baseline; up to 20 weeks

Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period

Time frame: Baseline; up to 20 weeks

Number of Participants Receiving Epoetin Alfa Rescue

Time frame: up to 20 weeks

Number of Participants Receiving Red Blood Cell Transfusion

Time frame: up to 20 weeks

Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor

Time frame: up to 20 weeks

Mean Weekly Dose of Intravenous Elemental Iron Administered

Time frame: up to 20 weeks

Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%)

Time frame: up to 20 weeks

Number of Participants Utilizing Resources

Time frame: up to 20 weeks

Number of Participants With Treatment-emergent Adverse Events

Treatment-emergent adverse events were collected in all participants enrolled in the study.

Data from ClinicalTrials.gov

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