A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Phase 3
Completed
- Conditions
- Anemia
- Interventions
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
- Registration Number
- NCT00442793
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). 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
- 265
Inclusion Criteria
- adult patients, >=18 years of age;
- chronic renal anemia requiring dialysis;
- maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
- adequate iron status.
Exclusion Criteria
- previous epoetin treatment within 8 weeks prior to screening;
- failing renal graft in place;
- bleeding episode necessitating transfusion within 8 weeks prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 methoxy polyethylene glycol-epoetin beta [Mircera] - 2 Epoetin beta -
- Primary Outcome Measures
Name Time Method Hb response rate Weeks 0-24 Change in Hb concentration between baseline and evaluation period Months 4-6
- Secondary Outcome Measures
Name Time Method Hb over time Throughout study Time to Hb response Throughout study RBC transfusions Weeks 0-24 AEs, laboratory parameters, vital signs Throughout study Serum concentration of Mircera Throughout study