Status:
COMPLETED
Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
Novartis
University of Washington
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Current therapy to prevent organ rejection relies on the use of calcineurin inhibitors either cyclosporine or tacrolimus. Although these agents have been very successful in preventing early acute reje...
Detailed Description
The purpose of this study is to determine if tacrolimus can be safely lowered to potentially non-nephrotoxic levels or discontinued completely in favor of Rapamycin 3 months after kidney transplantati...
Eligibility Criteria
Inclusion
- All patients receiving their first renal allograft transplant will be considered eligible for study
- Patients receiving both living and cadaveric donors will be eligible
Exclusion
- If less than 18 years of age
- Severe hyperlipidemia
- If pregnant or cannot comply with proper birth control during the study
- Recipients of kidney together with another solid organ or bone marrow transplant
- Patients receiving any investigational medications or participating in a clinical trial
- Patients receiving a second or third renal allograft
- PRA \> 30%
- Active infections
- Chronic antiarrhythmic therapy for ventricular arrhythmia
- Malignancy except for basal cell carcinoma
- HIV
- ANC count \< 1,000/ mm3, Platelet count \< 100,00/mm3
- Fasting triglycerides \> 400 mg/dl and cholesterol \> 300 mg/dl
- HCV-positive, HBVSAg-positive, HBVCoreAb-positive and HBVSAntibody negative or HCV/HBV co-infected patients
- Breastfeeding women
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00896012
Start Date
January 1 2008
End Date
December 1 2011
Last Update
August 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Buffalo General Hospital Multi-Organ Transplant Department
Buffalo, New York, United States, 14203