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

Active:	No
Cancer Type:	Cancer-Related Syndrome Leukemia Myelodysplastic Syndromes (MDS)	NCT ID:	NCT03263091
Trial Phases:	Phase III	Protocol IDs:	FGCL-4592-082 (primary) NCI-2017-02071
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	FibroGen
NCI Full Details:	http://clinicaltrials.gov/show/NCT03263091

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.

Objectives

This study includes an Open-Label Lead in, a Double-Blind component, and an Open-Label High
Erythropoietin component. There is a screening period of up to 42 days followed by a
treatment period of 52 weeks and a 4-week end of treatment assessment.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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