Status:
COMPLETED
A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- chronic renal anemia;
- hemodialysis 3 times weekly for \>=12 weeks before screening, and during screening/baseline period;
- receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.
Exclusion
- overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
- transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
- active malignancy;
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT00394953
Start Date
December 1 2006
End Date
November 1 2008
Last Update
January 20 2017
Active Locations (88)
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1
Adelaide, Australia, SA 5000
2
Clayton, Australia, 3186
3
Gosford, Australia, 2250
4
Parkville, Australia, 3052