Status:
COMPLETED
Freedom Study: Myfortic in Kidney Transplant Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
Eligibility Criteria
Inclusion
- Males and females aged 18 to 75 years.
- Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.
Exclusion
- Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
- Kidneys from non-heart beating donors or HLA identical living related donors.
- ABO incompatibility against the donor.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT00101738
Start Date
March 1 2003
End Date
May 1 2005
Last Update
January 31 2011
Active Locations (44)
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1
UCSF Kidney Transplant Service
San Francisco, California, United States, 94143-0780
2
Livelink, Inc.
Tampa, Florida, United States, 33606
3
Loyola Medical Center
Maywood, Illinois, United States, 60153
4
Indiana U. Medical Center
Indianapolis, Indiana, United States, 46202