Status:
COMPLETED
A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.
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 subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis pati...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- chronic renal anemia;
- predialysis stage;
- no ESA therapy during previous 3 months.
Exclusion
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization in previous 6 months;
- significant acute or chronic bleeding.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00661388
Start Date
August 1 2008
End Date
December 1 2010
Last Update
September 11 2025
Active Locations (9)
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1
Ankara, Turkey (Türkiye), 06100
2
Denizli, Turkey (Türkiye), 20100
3
Edirne, Turkey (Türkiye), 22030
4
Istanbul, Turkey (Türkiye), 34000