Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants — Himalayas  

Anemia in Incident Dialysis Patients Clinical Trial

Official title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-Dialysis Patients

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.

Clinical Trial 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 participant is randomized, and a post-treatment follow-up period of 4 weeks. Participants will be randomized in a 1:1 ratio to receive either open-label roxadustat or epoetin alfa (active control). ;

Related Conditions & MeSH terms

• Anemia
• Anemia in Incident Dialysis Patients

• NCT number: NCT02052310
• Study type: Interventional
• Source: FibroGen
• Status: Completed
• Phase: Phase 3
• Start date: February 11, 2014
• Completion date: September 21, 2018