NCT01887600

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 594 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in patients with chronic kidney disease.

Detailed description

The study consisted of three study periods as follows: * Screening period: up to 6 weeks * Treatment period: minimum 52 weeks (primary treatment period) up to a maximum of 104 weeks (extended treatment period) * Post-Treatment Follow-Up period: 4 weeks

Conditions

• Anemia in Chronic Kidney Disease in Non-dialysis Patients

Interventions

Type	Name	Description
DRUG	Roxadustat	Roxadustat was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.
DRUG	Placebo	Placebo was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.

Timeline

• Start date: 2013-09-03
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2013-06-27
• Last updated: 2024-11-14
• Results posted: 2020-12-17

Locations

138 sites across 22 countries: Belarus, Belgium, Bulgaria, Colombia, Dominican Republic, Estonia, Georgia, Greece, Guatemala, Hungary, Italy, Panama, Peru, Poland, Romania, Russia, Serbia, South Africa, Spain, Turkey (Türkiye), Ukraine, United Kingdom