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Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

NCT03054350•Akebia Therapeutics

View on ClinicalTrials.gov

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent Chronic Kidney Disease (DD-CKD).

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female Japanese participants ≥20 years of age
•Receiving chronic maintenance hemodialysis for end-stage kidney disease
•Hemoglobin (Hb) \<10.0 grams per deciliter (g/dL)

Exclusion Criteria

•Anemia due to a cause other than chronic kidney disease (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

Locations (18)

Aichi, Japan

Ehime, Japan

Fukui, Japan

Hiroshima, Japan

Hokkaido, Japan

Hyōgo, Japan

Ibaraki, Japan

Kagoshima, Japan

Kochi, Japan

Miyagi, Japan

Key Dates

Start Date

December 1, 2016

Primary Completion Date

October 24, 2017

Completion Date

January 24, 2018

Last Updated

April 8, 2021

Enrollment

ACTUAL participants

Conditions

AnemiaDialysis Dependent Chronic Kidney Disease

Interventions

Vadadustat

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Inclusion Criteria

Exclusion Criteria

Natural History of Acquired and Inherited Bone Marrow Failure Syndromes

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