Last updated on July 2018

Safety and Efficacy Study for Treatment of Anemia in ESRD Newly Initiated Dialysis Patients

Brief description of study

The purpose of this study is to determine whether FG-4592 (roxadustat) is safe and effective in the treatment of anemia in patients who have just begun dialysis treatment for end stage renal disease.

Detailed Study Description

There is a screening period of up to 6 weeks, a treatment period of a minimum of 52 weeks and a maximum of approximately up to 3 years after last patient is randomized, and a post-treatment follow-up period of 4 weeks. A total of up to 900 patients will be randomized in a 1:1 ratio to receive either open-label FG-4592 or Active Control (Epoetin alfa).

Clinical Study Identifier: NCT02052310

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Trial Coordinator

Investigational Site
Houston, TX United States