NCT02652819

FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of anemia in subjects with CKD not on dialysis, with treatment up to 52 weeks.

Detailed description

This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of anemia in subjects with CKD not on dialysis. Eligible subjects are randomized to FG-4592 or placebo at a ratio of 2:1. The primary endpoint is change in Hb from baseline to the average level during Weeks 7 to 9 inclusive.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	FG-4592
DRUG	Placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-01-24
• Completion: 2017-06-13
• First posted: 2016-01-12
• Last updated: 2017-08-24

Locations

30 sites across 1 country: China