Status:
TERMINATED
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epo...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- chronic kidney disease stage IV not requiring dialysis;
- expected to initiate dialysis within 18 months;
- 15\<=Glomerular Filtration Rate (GFR)\<=29.
Exclusion
- failing renal allograft in place;
- acute or chronic bleeding within 8 weeks prior to screening;
- transfusion of red blood cells within 8 weeks prior to screening;
- poorly controlled hypertension;
- immunosuppressive therapy in the 12 weeks prior to screening.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00454246
Start Date
April 1 2007
End Date
February 1 2008
Last Update
December 16 2011
Active Locations (78)
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Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Phoenix, Arizona, United States
4
El Dorado, Arkansas, United States