Status:
COMPLETED
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
Lead Sponsor:
Novartis
Conditions:
Kidney Transplantation
Graft Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
Eligibility Criteria
Inclusion
- Male and female patients of any race between 18 to 70 years old (inclusive)
- Patients who gave written informed consent to participate in the study
Exclusion
- Recipients of multi-organ transplantation
- Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA) identical living donor kidney transplantation.
- Graft cold ischemia time greater than 40 hours.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
833 Patients enrolled
Trial Details
Trial ID
NCT00251004
Start Date
October 1 2005
End Date
October 1 2009
Last Update
May 10 2011
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936