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

Phase 2

Terminated

• Conditions: Dialysis-Dependent Chronic Kidney Disease; Anemia
• Interventions: Drug: epoetin alfa; Drug: vadadustat

• Registration Number: NCT03140722
• Lead Sponsor: Akebia Therapeutics

Brief 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.)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-04
• Primary Completion: 2018-03-21
• Study Completion: 2018-03-21
• Disposition First Submitted: 2018-09-15
• Disposition First Submitted QC: 2018-09-15
• Disposition First Posted: 2018-09-19
• Status Verified: 2021-02
• Results First Submitted: 2021-02-02
• Results First Submitted QC: 2021-02-02
• Last Update Submitted: 2021-02-02
• Results First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
epoetin alfa	epoetin alfa	Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study
vadadustat	vadadustat	Vadadustat daily oral dose, adjustable based on Hb level

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period	Baseline; up to 20 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period	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	Baseline; up to 20 weeks
Number of Participants Receiving Epoetin Alfa Rescue	up to 20 weeks
Number of Participants Receiving Red Blood Cell Transfusion	up to 20 weeks
Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor	up to 20 weeks
Mean Weekly Dose of Intravenous Elemental Iron Administered	up to 20 weeks
Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%)	up to 20 weeks
Number of Participants Utilizing Resources	up to 20 weeks
Number of Participants With Treatment-emergent Adverse Events	up to 24 weeks	Treatment-emergent adverse events were collected in all participants enrolled in the study.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Norfolk, Virginia, United States