Status:
COMPLETED
A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglob...
Eligibility Criteria
Inclusion
- chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
- continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.
Exclusion
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding;
- poorly controlled hypertension.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00642967
Start Date
June 1 2008
End Date
August 1 2010
Last Update
September 14 2021
Active Locations (69)
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1
Aix-en-Provence, France, 13090
2
Angers, France, 49000
3
Angers, France, 49933
4
Annonay, France, 07103