A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
Phase 3
Completed
- Conditions
- Anemia
- Interventions
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Drug: epoetin alfa or beta
- Registration Number
- NCT00081484
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
Inclusion Criteria
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving iv or sc epoetin for at least 8 weeks before screening.
Exclusion Criteria
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or during the study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 methoxy polyethylene glycol-epoetin beta [Mircera] - 2 epoetin alfa or beta -
- Primary Outcome Measures
Name Time Method Change in hemoglobin concentration Weeks 1-36
- Secondary Outcome Measures
Name Time Method AEs, laboratory parameters, vital signs Throughout study Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration Weeks 29-36 RBC transfusions Weeks 1-36