A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Overview
- Phase
- Phase 4
- Intervention
- Dialysis
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 86
- Primary Endpoint
- Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility 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)
Arms & Interventions
Single Arm
Intervention: Dialysis
Single Arm
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Outcomes
Primary Outcomes
Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
Time Frame: Weeks 1 to 32
Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter \[g/dL\]) throughout the treatment period were reported.
Secondary Outcomes
- Mean Monthly Hb Values(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8)
- Change in Hb Concentration Between Reference and Treatment Period(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8)
- Mean Time Participants Spent Having Hb Concentration Within Target Range(Weeks 1 to 32)
- Percentage of Participants Requiring Dose Adjustments(Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8)