Status:
COMPLETED
A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobi...
Eligibility Criteria
Inclusion
- Chronic renal anemia;
- Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month;
- Regular long term hemodialysis therapy with the same mode of dialysis for \>=3 months.
Exclusion
- Transfusion of red blood cells during previous 2 months;
- Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- Active malignant disease (except non-melanoma skin cancer).
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00699348
Start Date
July 1 2008
End Date
July 1 2010
Last Update
April 6 2016
Active Locations (60)
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1
Acireale, Italy, 95024
2
Ancona, Italy, 60121
3
Anzio, Italy, 00042
4
Arenzano, Italy, 16011