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

February 2, 2021 updated by: Akebia Therapeutics

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Research Site
      • Elk Grove, California, United States, 95758
        • Research Site
      • Encino, California, United States, 91316
        • Research Site
      • Escondido, California, United States, 92025
        • Research Site
      • Lynwood, California, United States, 90262
        • Research Site
      • San Diego, California, United States, 92115
        • Research Site
      • San Luis Obispo, California, United States, 93401
        • Research Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • Miami, Florida, United States, 33183
        • Research Site
      • Orlando, Florida, United States, 32804
        • Research Site
    • Georgia
      • Statesboro, Georgia, United States, 30458
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48224
        • Research Site
    • New York
      • Bronx, New York, United States, 10473
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Research Site
    • Texas
      • El Paso, Texas, United States, 79915
        • Research Site
      • Houston, Texas, United States, 77070
        • Research Site
    • Virginia
      • Newport News, Virginia, United States, 23605
        • Research Site
      • Norfolk, Virginia, United States, 23502
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vadadustat
Vadadustat daily oral dose, adjustable based on Hb level
Drug: vadadustat
vadadustat
Other Names:
  • AKB-6548
ACTIVE_COMPARATOR: epoetin alfa
Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study
Drug: epoetin alfa
epoetin alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period
Time Frame: Baseline; up to 20 weeks
Baseline; up to 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period
Time Frame: Baseline; up to 20 weeks
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
Baseline; up to 20 weeks
Number of Participants Receiving Epoetin Alfa Rescue
Time Frame: up to 20 weeks
up to 20 weeks
Number of Participants Receiving Red Blood Cell Transfusion
Time Frame: up to 20 weeks
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
up to 20 weeks
Mean Weekly Dose of Intravenous Elemental Iron Administered
Time Frame: up to 20 weeks
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
up to 20 weeks
Number of Participants Utilizing Resources
Time Frame: up to 20 weeks
up to 20 weeks
Number of Participants With Treatment-emergent Adverse Events
Time Frame: up to 24 weeks
Treatment-emergent adverse events were collected in all participants enrolled in the study.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akebia Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2017

Primary Completion (ACTUAL)

March 21, 2018

Study Completion (ACTUAL)

March 21, 2018

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (ACTUAL)

May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKB-6548-CI-0018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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