Status:
COMPLETED
A Study of Intravenous Mircera for the Treatment of Anemia 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 and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on ...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- chronic renal anemia;
- longterm hemodialysis for \>=12 weeks before screening;
- baseline Hb between 10 and 13g/dL;
- iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for \>=4 weeks before screening.
Exclusion
- acute or chronic bleeding within 8 weeks prior to screening;
- transfusion of red blood cells within 8 weeks prior to screening;
- poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
- previous treatment with Mircera.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT00413894
Start Date
March 1 2007
End Date
October 1 2008
Last Update
February 15 2016
Active Locations (105)
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1
Aachen, Germany, 52066
2
Aachen, Germany, 52074
3
Alzey, Germany, 55232
4
Ansbach, Germany, 91522