Status:
COMPLETED
A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants wit...
Eligibility Criteria
Inclusion
- regular long term hemodialysis with same schedule for greater than or equal to (\>=) 12 weeks
- continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose
Exclusion
- transfusion of red blood cells during previous 2 months
- significant acute or chronic bleeding
- poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months
- weekly dose of epoetin beta greater than (\>) 16000 international units (IU), or weekly dose of darbepoetin alfa \>80 micrograms during previous month
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT00717821
Start Date
August 1 2008
End Date
July 1 2011
Last Update
September 14 2021
Active Locations (89)
Enter a location and click search to find clinical trials sorted by distance.
1
Abbeville, France, 80103
2
Albi, France, 81030
3
Amilly, France, 45200
4
Angers, France, 49933