NCT01750190

A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 922 (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 with chronic kidney disease and not on dialysis.

Detailed description

There is a screening period of up to 6 weeks, a variable treatment period for individual participants. In order to complete the treatment period simultaneously for all study participants, the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration of up to 3 years after the last participant is randomized, and a post-treatment follow-up period of 4 weeks. Participants who prematurely discontinued from treatment will be expected to complete the Early Termination (ET) and End of Study (EOS) visits. Such participants will be considered non-completers, but they will be expected to participate in long-term follow-up (LTFU) for cardiovascular events (CV) of interest, vital status, and hospitalizations until overall study closure unless the participant withdrew consent for this LTFU data collection. Participants were randomized in a 2:1 ratio to receive either roxadustat or placebo in a double-blind manner.

Conditions

• CKD Anemia

Interventions

Type	Name	Description
DRUG	Roxadustat	Oral tablets
DRUG	Placebo	Oral tablets

Timeline

• Start date: 2012-11-05
• Primary completion: 2018-09-24
• Completion: 2018-09-24
• First posted: 2012-12-17
• Last updated: 2021-10-01
• Results posted: 2021-10-01

Locations

145 sites across 16 countries: United States, Argentina, Australia, Chile, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Peru, Philippines, Puerto Rico, Singapore, South Korea, Taiwan, Thailand

Regulatory

• FDA-regulated drug study