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NCT03140722 Clinical Trial

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

Anemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03140722
Other study ID # AKB-6548-CI-0018
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 2, 2017
Est. completion date March 21, 2018

Study information
Verified date February 2021
Source Akebia Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.)

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date March 21, 2018
Est. primary completion date March 21, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• vadadustat
vadadustat
• epoetin alfa
epoetin alfa

Locations
Country Name City State
United States Research Site Bakersfield California
United States Research Site Bronx New York
United States Research Site Detroit Michigan
United States Research Site El Paso Texas
United States Research Site Elk Grove California
United States Research Site Encino California
United States Research Site Escondido California
United States Research Site Houston Texas
United States Research Site Lynwood California
United States Research Site Miami Florida
United States Research Site Newport News Virginia
United States Research Site Norfolk Virginia
United States Research Site Orlando Florida
United States Research Site Philadelphia Pennsylvania
United States Research Site San Diego California
United States Research Site San Luis Obispo California
United States Research Site Statesboro Georgia
United States Research Site Waterbury Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period Baseline; up to 20 weeks
Secondary Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period Baseline; up to 20 weeks
Secondary Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period Baseline; up to 20 weeks
Secondary Number of Participants Receiving Epoetin Alfa Rescue up to 20 weeks
Secondary Number of Participants Receiving Red Blood Cell Transfusion up to 20 weeks
Secondary Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor up to 20 weeks
Secondary Mean Weekly Dose of Intravenous Elemental Iron Administered up to 20 weeks
Secondary Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin =100 Nanograms Per Milliliter and Transferrin Saturation =20%) up to 20 weeks
Secondary Number of Participants Utilizing Resources up to 20 weeks
Secondary Number of Participants With Treatment-emergent Adverse Events Treatment-emergent adverse events were collected in all participants enrolled in the study. up to 24 weeks
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