Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease

Phase 4 Completed 318 enrolled Kyntra Bio

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period. There are 3 study periods: * Screening Period (up to 4 weeks) * Treatment Period (36 weeks) Part 1: Correction/Conversion Period (Weeks 1-20) Part 2: Hemoglobin (Hb) Maintenance Period (Weeks 21-36) * Follow-up Period (4 weeks)

Timeline

Start: 2019-06-11
Primary completion: 2021-11-19
Completion: 2021-12-17

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	Roxadustat	Small molecule	70 mg	Oral
Subject	Roxadustat	Small molecule	100 mg	Oral
Subject	Roxadustat	Small molecule	120 mg	Oral

Indications

No indication recorded.