ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

NCT01964196 ↗

Phase 2 Completed 107 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently.

Timeline

Start: 2013-09-17
Primary completion: 2015-07-06
Completion: 2015-12-01

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.
Akizawa T, Iwasaki M, Otsuka T, Reusch M, Misumi T. Roxadustat Treatment of Chronic Kidney Disease-Associated Anemia in Japanese Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. Adv Ther. 2019 Jun;36(6):1438-1454. doi: 10.1007/s12325-019-00943-4. Epub 2019 Apr 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roxadustat	Small molecule	50 mg	Oral
Subject	Roxadustat	Small molecule	70 mg	Oral
Subject	Roxadustat	Small molecule	100 mg	Oral

Indications

No indication recorded.