NCT00491868

Clinical Study of R744 to Hemodialysis Patients

Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase III, Double Blind Study in Comparison With Epoetin Beta).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of intravenous injections of R744 in renal anemia patients on Hemodialysis patients.

Conditions

• Hemodialysis Patients

Interventions

Type	Name	Description
DRUG	R744	100μg/4week for 8 weeks, then 50\~250μg/4week for 16 weeks
DRUG	R744	150μg/4week for 8 weeks, then 50\~250μg/4week for 16 weeks
DRUG	rHuEPO	2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750\~9000IU(i.v.)/1\~3week for 16 weeks
DRUG	rHuEPO	4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750\~9000IU(i.v.)/1\~3week for 16 weeks
DRUG	R744 placebo	0 μg/4week for 24 weeks
DRUG	rHuEPO placebo	0 IU 2 or 3 times/week for 8 weeks, then 1\~3 times/week for 16 weeks

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-05-01
• Completion: 2008-08-01
• First posted: 2007-06-26
• Last updated: 2009-02-02

Locations

5 sites across 1 country: Japan