Status:
TERMINATED
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa,...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- CKD (stage V) on outpatient hemodialysis therapy for \>= 3 months;
- CKD-related anemia treated with epoetin alfa iv 3x/week for \>= 3 months;
- average hemoglobin (Hb) 10-12 g/dL over last 3 months.
Exclusion
- failed renal transplant within 12 months prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00422513
Start Date
March 1 2007
End Date
December 1 2007
Last Update
December 14 2011
Active Locations (44)
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1
Birmingham, Alabama, United States
2
Rainbow City, Alabama, United States
3
Hot Springs, Arizona, United States
4
Fairfield, California, United States