Status:
COMPLETED
STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
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 Mircera for the maintenance of hemoglobin levels in dialysis participants with chr...
Eligibility Criteria
Inclusion
- Chronic renal anemia;
- Continuous stable intravenous maintenance epoetin therapy during previous month;
- Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Exclusion
- Transfusion of red blood cells during previous 2 months;
- Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
- Significant acute or chronic bleeding.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00642850
Start Date
November 1 2007
End Date
July 1 2009
Last Update
June 23 2016
Active Locations (24)
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1
Brno, Czechia, 656 91
2
Český Krumlov, Czechia, 38127
3
Děčín, Czechia, 405 99
4
Havířov, Czechia, 736 24