NCT02052310

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,043 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Anemia in Incident Dialysis Patients

Interventions

Type	Name	Description
DRUG	Roxadustat	Roxadustat will be administered per dose and schedule specified in the arm.
DRUG	Epoetin Alfa	Epoetin alfa will be administered TIW according to the epoetin alfa USPI or SmPC, or local SOC.

Timeline

• Start date: 2014-02-11
• Primary completion: 2018-09-21
• Completion: 2018-09-21
• First posted: 2014-02-03
• Last updated: 2021-10-01
• Results posted: 2021-10-01

Locations

113 sites across 15 countries: United States, Argentina, Bulgaria, Chile, Colombia, Latvia, Malaysia, Mexico, Poland, Romania, Russia, South Korea, Taiwan, Thailand, Ukraine

Regulatory

• FDA-regulated drug study