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

Phase 2 Completed 60 enrolled Akebia Therapeutics

RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start: 2016-12
Primary completion: 2017-10-24
Completion: 2018-01-24

Outcome

Met primary endpoint

registry analysis (superiority test); Vadadustat 150 mg vs Placebo; p = 0.0004; Least squares mean difference 1.19 (95% CI 0.56 to 1.82); ANCOVA NCT03054350 ↗

release “Statistically significant improvements in the primary endpoint were observed in the vadadustat groups” akebia.com ↗

Publications

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vadadustat	Small molecule	—	Oral