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

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Methoxy polyethylene glycol-epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00737477

2008-001747-18 (EudraCT Number)

ML21421

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Mircera in Renal Anemia

Experimental group

Description:

Participants will receive SC methoxy polyethylene glycol-epoetin beta (Mircera) every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta