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

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

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.

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.