20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Summary

The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.

Timeline

Start

2013-07-23

Primary completion

2014-09-03

Completion

2014-09-03

Outcome

Met primary endpoint

paper Significantly, the primary endpoint was met in 54.9% of patients on vadadustat and 10.3% of patients on placebo. PMID 27650732 ↗

registry analysis (superiority test); Vadadustat vs Placebo; p =0.0001; Odds Ratio (OR) 11.4739 (95% CI 3.3505 to 39.2931); Fisher Exact NCT01906489 ↗

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.
• Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH. Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease. Kidney Int. 2016 Nov;90(5):1115-1122. doi: 10.1016/j.kint.2016.07.019. Epub 2016 Sep 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vadadustat	Small molecule	—	Oral

Indications