A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis

• Status: Completed
• Trial end date: 2011-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Adults greater than or equal to (≥) 18 years of age

• Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months

• Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start

Exclusion Criteria:

• Transfusion of red blood cells during previous 8 weeks

• Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months

• Significant acute or chronic bleeding during previous 8 weeks