NCT02652806

FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease

A Phase 3, Randomized, Open-Label, Active-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease on Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.

Detailed description

This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis. Eligible subjects are randomized to FG-4592 or epoetin alfa at a ratio of 2:1. The primary endpoint is Hb mean change from baseline averaged over Weeks 23 to 27.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	FG-4592
DRUG	Epoetin Alfa

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-01-24
• Completion: 2017-06-14
• First posted: 2016-01-12
• Last updated: 2017-08-24

Locations

31 sites across 1 country: China