CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Vadadustat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03054337
NCT03054337Phase 2Completed

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 Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)

Akebia Therapeutics·interventional·Posted Feb 15, 2017·Updated Apr 8, 2021

In Brief

A Phase 2 clinical trial evaluating Vadadustat and Placebo for Anemia and Non-dialysis Dependent Chronic Kidney Disease. Completed, enrolled 51 participants across 18 sites.

Detailed 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 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 15, 2017
Enrollment StartOct 1, 2016
Primary CompletionJul 4, 2017
Study CompletionAug 28, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.4 years ago

Interventions

Vadadustatdrug

Placebodrug