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

Phase 2 Completed 51 enrolled Akebia Therapeutics

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

Timeline

Start: 2016-10
Primary completion: 2017-07-04
Completion: 2017-08-28

Outcome

Met primary endpoint

registry analysis (superiority test); Vadadustat 150 vs Placebo; p = 0.0045; Least squares mean difference 0.90 (95% CI 0.29 to 1.51); ANCOVA NCT03054337 ↗

registry analysis (superiority test); Vadadustat 300 mg vs Placebo; p <0.0001; Least squares mean difference 1.59 (95% CI 0.98 to 2.21); ANCOVA NCT03054337 ↗

registry analysis (superiority test); Vadadustat 600 mg vs Placebo; p <0.0001; Least squares mean difference 2.09 (95% CI 1.49 to 2.70); ANCOVA NCT03054337 ↗

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