NCT00492427

Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)

Correction and Maintenance Study of Subcutaneous Injections of R744 to Predialysis Patients ( Phase III, Comparative Study in Comparison With Epoetin Beta)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 187 (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 subcutaneous R744 in renal anemia patients on Predialysis.

Conditions

• Predialysis Patients

Interventions

Type	Name	Description
DRUG	R744	25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25\~250μg(s.c.)/4week for 24\~26weeks in total.
DRUG	Epoetin beta	6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k\~12000IU(s.c.)/2week for 24\~26weeks in total.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-01-01
• Completion: 2008-11-01
• First posted: 2007-06-27
• Last updated: 2009-01-08

Locations

6 sites across 1 country: Japan