A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.

Anemia Clinical Trial

Official title: An Open Label Randomized Controlled Study to Compare the Efficacy and Safety of Once Every 4 Weeks Administration of Mircera Versus Short-acting Epoetin for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia.

Status Completed

Clinical Trial Summary

This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

• NCT number: NCT00773331
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Completed
• Phase: Phase 3
• Start date: July 2009
• Completion date: December 2010