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Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

NCT02865850 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2022-07-18

Study results available
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Summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).

Conditions

  • Anemia
  • Dialysis-Dependent Chronic Kidney Disease

Interventions

DRUG

Vadadustat

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

DRUG

Darbepoetin alfa

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.

Sponsors & Collaborators

  • Akebia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Akebia Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2020-01-31
Completion
2020-03-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Germany
  • Italy
  • Mexico
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02865850 on ClinicalTrials.gov