Status:
COMPLETED
A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are 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 intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels...
Eligibility Criteria
Inclusion
- Adults greater than or equal to (≥) 18 years of age
- Chronic renal anemia
- Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
- Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months
Exclusion
- Transfusion of red blood cells during previous 2 months
- Poorly controlled hypertension
- Significant acute or chronic bleeding
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00660023
Start Date
August 1 2008
End Date
November 1 2010
Last Update
March 15 2016
Active Locations (10)
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1
Baja, Hungary, 6500
2
Budapest, Hungary, 1062
3
Debrecen, Hungary, 4032
4
Esztergom, Hungary, 2500