A Study of Mircera for the Treatment of Anemia in Dialysis Patients
Phase 3
Completed
- Conditions
- Anemia
- Interventions
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Drug: epoetin
- Registration Number
- NCT00077597
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
Inclusion Criteria
- adult patients >=18 years of age;
- chronic renal anemia;
- dialysis therapy for at least 2 weeks before screening.
Exclusion Criteria
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 4 weeks before screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 methoxy polyethylene glycol-epoetin beta [Mircera] - 2 epoetin -
- Primary Outcome Measures
Name Time Method Hemoglobin response rate Weeks 1-24
- Secondary Outcome Measures
Name Time Method Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n Throughout study