NCT01630889

Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease

Open-Label Extension Study to Evaluate the Efficacy and Safety of FG-4592 for the Long-Term Maintenance Treatment of Anemia in Dialysis and Non-Dialysis Patients With Chronic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study.

Detailed description

This is an open-label, long-term maintenance study of roxadustat anemia therapy in participants with dialysis and non-dialysis CKD who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study. Participants assigned to roxadustat in the previous study will continue to receive the same roxadustat dose and dosing frequency, unless a dose adjustment is required.

Conditions

• Chronic Kidney Disease
• End Stage Renal Disease
• Anemia

Interventions

Type	Name	Description
DRUG	Roxadustat	Oral capsule

Timeline

• Start date: 2012-05-18
• Primary completion: 2019-12-12
• Completion: 2019-12-12
• First posted: 2012-06-28
• Last updated: 2021-10-01
• Results posted: 2021-10-01

Locations

7 sites across 2 countries: United States, Puerto Rico