NCT01147666

Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis

A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) and Single-Blind Placebo-Controlled, Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.

Detailed description

Dose ranging study with consecutive cohorts in two participant populations: participants normally responding to current anemia treatment (epoetin alfa) ("normoresponders": participants with baseline epoetin alfa dose at study entry 75 to 450 international units \[IU\]/kilograms \[kg\]/week) and participants not responding well to current treatment ("hyporesponders": participants with maintenance epoetin alfa dose above 450 IU/kg/week). Normoresponders are randomized to study drug roxadustat or epoetin alfa at a ratio of 3:1; hyporesponders are randomized to study drug roxadustat or epoetin alfa or placebo at a ratio of 2:1:1. The study objectives are to demonstrate that roxadustat is effective in maintaining hemoglobin (Hb) levels when converting from epoetin alfa and to establish optimum starting doses and dose adjustment regimens for Hb maintenance.

Conditions

• End Stage Renal Disease
• Anemia

Interventions

Type	Name	Description
DRUG	Roxadustat	Roxadustat will be administered per dose and schedule specified in the arms.
DRUG	Epoetin Alfa	Epoetin Alfa will be administered per dose and schedule specified in the arms.
OTHER	Placebo	Placebo matching to roxadustat will be administered per schedule specified in the arm.

Timeline

• Start date: 2010-05-17
• Primary completion: 2012-10-15
• Completion: 2012-10-15
• First posted: 2010-06-22
• Last updated: 2022-01-11
• Results posted: 2022-01-11

Locations

25 sites across 1 country: United States