Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

December 14, 2023 updated by: Akebia Therapeutics

A Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following randomization, there will be 2 periods during the study:

  • Conversion and Maintenance Period (Weeks 0 to 52): There will be a primary efficacy evaluation period (Weeks 20 to 26) and a secondary efficacy evaluation period (Weeks 46 to 52).
  • Safety Follow-up Period (Early Termination [ET] and Follow-Up): post-treatment safety follow-up visit (ET/End of Treatment [EOT] +4 weeks) either in person or via telephone.

Study Type

Interventional

Enrollment (Actual)

456

Phase

  • Phase 3

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
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85035
        • Research Site
    • Arkansas
      • Pine Bluff, Arkansas, United States, 71603
        • Research Site
    • California
      • El Centro, California, United States, 92243
        • Research Site
      • Escondido, California, United States, 92025
        • Research Site
      • Fresno, California, United States, 93720
        • Research Site
      • Granada Hills, California, United States, 91344
        • Research Site
      • Porterville, California, United States, 93257
        • Research Site
      • San Diego, California, United States, 92111
        • Research Site
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Research Site
      • Denver, Colorado, United States, 80210
        • Research Site
    • Delaware
      • Hockessin, Delaware, United States, 19707
        • Research Site
    • Florida
      • Bradenton, Florida, United States, 34209
        • Research Site
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • Coral Springs, Florida, United States, 33071
        • Research Site#1
      • Coral Springs, Florida, United States, 33071
        • Research Site#2
      • Jacksonville, Florida, United States, 32216
        • Research Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Research Site
      • Buford, Georgia, United States, 30518
        • Research Site
      • Dalton, Georgia, United States, 30720
        • Research Site
      • Macon, Georgia, United States, 31201
        • Research Site
    • Idaho
      • Nampa, Idaho, United States, 83687
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70884
        • Research Site
      • Shreveport, Louisiana, United States, 71101
        • Research Site
    • Massachusetts
      • Plymouth, Massachusetts, United States, 02360
        • Research Site
      • Springfield, Massachusetts, United States, 01107
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Research Site
      • Rochester Hills, Michigan, United States, 48309
        • Research Site
      • Saint Clair Shores, Michigan, United States, 48081
        • Research Site
    • Mississippi
      • Brookhaven, Mississippi, United States, 39601
        • Research Site
      • Columbus, Mississippi, United States, 39705
        • Research Site
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Nebraska
      • North Platte, Nebraska, United States, 69101
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89115
        • Research Site
      • Reno, Nevada, United States, 89511
        • Research Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Research Site
      • Gallup, New Mexico, United States, 87301
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Research Site
      • Durham, North Carolina, United States, 27704
        • Research Site
      • Kinston, North Carolina, United States, 28504
        • Research Site
      • Raleigh, North Carolina, United States, 27609
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Research Site
    • Pennsylvania
      • Kittanning, Pennsylvania, United States, 16201
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76015
        • Research Site
      • Austin, Texas, United States, 78758
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Dallas, Texas, United States, 75230
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77099
        • Research Site
      • Mansfield, Texas, United States, 76063
        • Research Site
      • Mission, Texas, United States, 78572
        • Research Site
      • San Antonio, Texas, United States, 78251
        • Research Site
      • San Antonio, Texas, United States, 78211
        • Research Site
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Research Site
      • Salem, Virginia, United States, 24153
        • Research Site
      • Woodbridge, Virginia, United States, 22192
        • 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

Description

Inclusion Criteria:

  • ≥18 years of age
  • Receiving chronic, outpatient in-center hemodialysis three times weekly (TIW) for end-stage kidney disease for at least 12 weeks prior to Screening Visit 1 (SV1)
  • Currently maintained on Mircera® with at least 2 doses received within 8 weeks prior to Screening Visit 2 (SV2)
  • Mean Screening hemoglobin (Hb) between 8.5 and 11.0 grams per deciliter (g/dL) (inclusive), as determined by the average of 2 Hb values measured by the central laboratory at least 4 days apart between SV1 and SV2
  • Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
  • Folate and vitamin B12 measurements ≥ lower limit of normal during Screening

Exclusion Criteria:

  • Anemia due to a cause other than chronic kidney disease (CKD).
  • Clinically meaningful bleeding event within 8 weeks prior to Baseline
  • Red blood cell (RBC) transfusion within 8 weeks prior to Baseline
  • Having received any doses of darbepoetin alfa (Aranesp®) within 4 weeks prior to Baseline
  • Having received any doses of epoetin alfa (Epogen®) within 1 week prior to Baseline.
  • Current uncontrolled hypertension.
  • Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening.
  • Known hypersensitivity to vadadustat, Mircera®, or any of their excipients.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mircera®
Participants will continue to receive Mircera® for up to 52 weeks.
Drug: Mircera®
intravenous administration
Experimental: Vadadustat low dose
Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 600 milligrams (mg).
Drug: Vadadustat
oral tablets
Experimental: Vadadustat high dose
Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 900 mg.
Drug: Vadadustat
oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in hemoglobin (Hb) between Baseline (average pretreatment Hb) and the primary evaluation period (average Hb from Weeks 20 to 26, inclusive)
Time Frame: Baseline; Weeks 20-26
Baseline; Weeks 20-26
Number of participants with treatment-emergent non-serious adverse events and treatment-emergent serious adverse events
Time Frame: up to Week 56
up to Week 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in Hb between Baseline (average pretreatment Hb) and the secondary evaluation period (average Hb from Weeks 46 to 52, inclusive)
Time Frame: Baseline; Weeks 46-52
Baseline; Weeks 46-52

Collaborators and Investigators

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

Sponsor

Akebia Therapeutics

Investigators

  • Study Director: Chief Medical Officer, Akebia Therapeutics Inc.

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)

June 18, 2021

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKB-6548-CI-0039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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