Status:
COMPLETED
A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with...
Eligibility Criteria
Inclusion
- male or female patients, \>=18 years of age;
- chronic renal anemia;
- Hb concentration 10.0 - 12.0 g/dL during the screening period;
- continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughout screening.
Exclusion
- blood transfusion within the previous 8 weeks;
- poorly controlled hypertension;
- significant or acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT00773331
Start Date
July 1 2009
End Date
December 1 2010
Last Update
November 2 2016
Active Locations (13)
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1
Beijing, China, 100034
2
Beijing, China, 100044
3
Beijing, China, 100050
4
Beijing, China, 100083