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Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa

NCT03799627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2022-09-29

Study results available
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Summary

This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.

Conditions

  • Anemia
  • Dialysis-dependent Chronic Kidney Disease

Interventions

DRUG

Vadadustat

Vadadustat Tablets 150 mg

DRUG

Epoetin Alfa

Epoetin Alfa

DRUG

Vadadustat TIW

Oral Vadadustat

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
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2020-06-05
Completion
2020-07-15
FDA Drug
Yes

Countries

  • United States

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 NCT03799627 on ClinicalTrials.gov