Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

Phase 3 Terminated 184 enrolled Kyntra Bio Astellas Pharma Inc · collab AstraZeneca · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.

Timeline

Start: 2018-01-29
Primary completion: 2023-03-09
Completion: 2023-06-20

Publications

Henry DH, Glaspy J, Harrup R, Mittelman M, Zhou A, Carraway HE, Bradley C, Saha G, Modelska K, Bartels P, Leong R, Yu KP. Roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndrome: Open-label, dose-selection, lead-in stage of a phase 3 study. Am J Hematol. 2022 Feb 1;97(2):174-184. doi: 10.1002/ajh.26397. Epub 2021 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roxadustat	Small molecule	1.5 mg/kg	Oral
Subject	Roxadustat	Small molecule	2 mg/kg	Oral
Subject	Roxadustat	Small molecule	2.5 mg/kg	Oral

Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

Summary

Timeline

Publications

Drugs

Indications