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

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Procedure: Dialysis; Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01156363

ML22299

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

86 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Procedure: Dialysis

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]