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Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Last Updated: 2022-06-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1725 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-07-31

Brief Summary

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A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

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Detailed Description

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This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with NDD-CKD

Conditions

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Anemia Non-Dialysis-Dependent Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Sponsor was blinded during the study

Study Groups

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Vadadustat

Group Type EXPERIMENTAL

Vadadustat

Intervention Type DRUG

Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Darbepoetin alfa

Group Type ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type DRUG

Subcutaneous or intravenous dose administered for ≥36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.

Interventions

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Vadadustat

Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Intervention Type DRUG

Darbepoetin alfa

Intervention Type DRUG

Other Intervention Names

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AKB-6548 Aranesp

Eligibility Criteria

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Inclusion Criteria

* ≥18 years of age
* Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) at Screening and not expected to start dialysis within 6 months of Screening
* Currently maintained on erythropoiesis-stimulating agents therapy, with a dose received within 6 weeks prior to or during Screening
* Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the United States (US) and between 9.0 and 12.0 g/dL (inclusive) outside of the US
* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Exclusion Criteria

* Anemia due to a cause other than CKD or participant with active bleeding or recent blood loss
* Red blood cell transfusion within 8 weeks prior to randomization
* Uncontrolled hypertension
* Severe heart failure at Screening (New York Heart Association Class IV)
* 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, or stroke within 12 weeks prior to or during Screening
* Hypersensitivity to Darbepoetin or Vadadustat or to any of their excipients

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chief Medical Officer

Role: STUDY_DIRECTOR

Akebia Therapeutics Inc.

Locations

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Research Site

Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Tuscumbia, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Research Site #1

Chula Vista, California, United States

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Chula Vista, California, United States

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El Centro, California, United States

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Fountain Valley, California, United States

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Glendale, California, United States

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Granada Hills, California, United States

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La Mesa, California, United States

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Laguna Hills, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Lynwood, California, United States

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Northridge, California, United States

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Northridge, California, United States

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Riverside, California, United States

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Roseville, California, United States

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Salinas, California, United States

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San Diego, California, United States

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San Dimas, California, United States

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San Dimas, California, United States

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Santa Ana, California, United States

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Santa Monica, California, United States

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Sherman Oaks, California, United States

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Thousand Oaks, California, United States

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Whittier, California, United States

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Whittier, California, United States

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Arvada, Colorado, United States

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Denver, Colorado, United States

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Westminster, Colorado, United States

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Stamford, Connecticut, United States

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Waterbury, Connecticut, United States

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Bradenton, Florida, United States

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Brandon, Florida, United States

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Cooper City, Florida, United States

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Research Site #1

Coral Gables, Florida, United States

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Research Site #2

Coral Gables, Florida, United States

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Coral Springs, Florida, United States

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Coral Springs, Florida, United States

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Doral, Florida, United States

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