Status:
TERMINATED
A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently 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 Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currentl...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- chronic renal anemia;
- no ESA therapy during previous 3 months;
- adequate iron status;
- rapid chronic kidney disease progression.
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 :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00680563
Start Date
April 1 2009
End Date
January 1 2010
Last Update
November 5 2013
Active Locations (22)
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1
Buenos Aires, Argentina, CP2700
2
La Plata, Argentina, 1900
3
San Miguel de Tucumán, Argentina, 4000
4
Blumenau, Brazil, 89010-500