NCT02273726

Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis

A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects With End Stage Renal Disease (ESRD) on Stable Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 741 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.

Detailed description

This study will consist of three study periods as follows: 1. Screening Period of up to 6 weeks (8 weeks if on Mircera) 2. Treatment Period: a minimum of 52 weeks, a maximum of up to 3 years from the date last participant is randomized. Minimum study duration for participants enrolled under Protocol Amendment 1 or 2 may be less than 52 weeks 3. A Follow-up period of 4 weeks. Participants will be randomized in a 1:1 ratio to receive either roxadustat or epoetin alfa (active control) in an open-label manner.

Conditions

• CKD Anemia in Stable Dialysis Patients

Interventions

Type	Name	Description
DRUG	Epoetin Alfa	Epoetin alfa will be administered per dose and schedule specified in the arm.
DRUG	Roxadustat	Roxadustat will be administered per dose and schedule specified in the arm.

Timeline

• Start date: 2015-01-15
• Primary completion: 2018-09-19
• Completion: 2018-09-19
• First posted: 2014-10-24
• Last updated: 2021-10-29
• Results posted: 2021-10-29

Locations

76 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study