Status:
TERMINATED
A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal 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 of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) ...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- chronic kidney disease stage V;
- on peritoneal dialysis for 3 months prior to screening;
- on epoetin alfa sc \>=3 months prior to screening.
Exclusion
- patients expecting to change dialysis modality over course of study;
- patients hospitalized during previous 3 months for any clinically significant condition;
- active malignancy;
- bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
- transfusion of red blood cells within 3 months prior to screening.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00442416
Start Date
February 1 2007
End Date
January 1 2008
Last Update
August 17 2016
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35213
2
Bakersfield, California, United States, 93309
3
Chula Vista, California, United States, 91910
4
Mountain View, California, United States, 94041