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, 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

Sponsors

Lead Sponsor: Akebia Therapeutics

Source 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 DD-CKD who are hyporesponsive to ESAs.

Overall Status Terminated
Start Date May 23, 2017
Completion Date April 11, 2018
Primary Completion Date March 21, 2018
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Evaluate the change in Hb from baseline over time 20 weeks
Secondary Outcome
Measure Time Frame
Proportion of subjects demonstrating incremental increases in Hb from baseline over time 20 weeks
Proportion of subjects receiving epoetin alfa rescue 20 weeks
Proportion of subjects receiving RBC transfusion 20 weeks
Proportion of subjects with Hb values within the target range 20 weeks
Adverse Events (AEs) and Serious Adverse Events (SAEs) 20 weeks
Enrollment 2
Condition
Intervention

Intervention Type: Drug

Intervention Name: vadadustat

Description: vadadustat

Arm Group Label: vadadustat

Other Name: AKB-6548

Intervention Type: Drug

Intervention Name: epoetin alfa

Description: epoetin alfa

Arm Group Label: epoetin alfa

Eligibility

Criteria:

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 at a dose of ≥7700 units per dialysis treatment session or ≥23100 units per week

- 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Akebia Therapeutics Study Director Sponsor GmbH
Location
Facility:
Research Site | Bakersfield, California, 93309, United States
Research Site | Elk Grove, California, 95758, United States
Research Site | Encino, California, 91316, United States
Research Site | Escondido, California, 92025, United States
Research Site | Lynwood, California, 90262, United States
Research Site | San Diego, California, 92115, United States
Research Site | San Luis Obispo, California, 93401, United States
Research Site | Waterbury, Connecticut, 06708, United States
Research Site | Miami, Florida, 33183, United States
Research Site | Orlando, Florida, 32804, United States
Research Site | Statesboro, Georgia, 30458, United States
Research Site | Detroit, Michigan, 48224, United States
Research Site | Bronx, New York, 10473, United States
Research Site | Philadelphia, Pennsylvania, 19106, United States
Research Site | El Paso, Texas, 79915, United States
Research Site | Houston, Texas, 77070, United States
Research Site | Newport News, Virginia, 23605, United States
Research Site | Norfolk, Virginia, 23502, United States
Location Countries

United States

Verification Date

November 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: vadadustat

Type: Experimental

Description: Vadadustat daily oral dose, adjustable based on Hb level

Label: epoetin alfa

Type: Active Comparator

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov