STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642850

ML21040

Details and patient eligibility

About

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic renal anemia;
• Continuous stable intravenous maintenance epoetin therapy during previous month;
• Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion criteria

• Transfusion of red blood cells during previous 2 months;
• Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
• Significant acute or chronic bleeding.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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188 participants in 1 patient group

1

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]