NCT00442793CompletedPhase 3
A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 265
- Primary Endpoint
- Hb response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
2
Active Comparator
Intervention: Epoetin beta (Drug)
Outcomes
Primary Outcomes
Hb response rate
Time Frame: Weeks 0-24
Change in Hb concentration between baseline and evaluation period
Time Frame: Months 4-6
Secondary Outcomes
- Hb over time(Throughout study)
- Serum concentration of Mircera(Throughout study)
- Time to Hb response(Throughout study)
- RBC transfusions(Weeks 0-24)
- AEs, laboratory parameters, vital signs(Throughout study)
Investigators
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