A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is <200 patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• adult patients, >/=18 years of age

• chronic renal anaemia

• haemoglobin 10.0-12.0g/dl at screening

• adequate iron status

• continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months

• regular haemodialysis or regular peritoneal dialysis for >/= 3 months

Exclusion Criteria:

• uncontrolled hypertension

• haemoglobinopathy

• anaemia due to haemolysis

• pure red cell aplasia (PRCA)