Status:
COMPLETED
Comparison of Sirolimus to Tacrolimus for Long Term Therapy in Kidney Transplant With no Steroids
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Genzyme, a Sanofi Company
Conditions:
Kidney Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Kidney transplant patients will be treated with Thymoglobulin (5 days), tacrolimus (Prograf), and mycophenolate mofetil (Cellcept) from the time of transplant. They will only receive steroids for 4 da...
Detailed Description
Abstract: Corticosteroids have been a mainstay of immunosuppression for kidney transplantation, but they are associated with significant toxicity after long-term use. Recent studies have concluded th...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Primary deceased or living donor renal transplant recipients
- Re-transplant recipients for which the first kidney transplant was lost for technical reasons with no sensitization (panel-reactive antibody \[PRA\] \< 20%) or 1st lost due to recurrent disease, that is not steroid responsive.
- Age \> 18
- Negative pregnancy test if female and of childbearing age. In addition, females of childbearing age must agree to use effective contraception for the duration of the study.
- Patient must sign informed consent prior to transplant.
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00170053
Start Date
June 1 2005
End Date
September 1 2008
Last Update
July 31 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Jacksonville, Florida, United States, 32224