Status:
COMPLETED
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
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
18-75 years
Phase:
PHASE4
Brief Summary
This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.
Detailed Description
The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. Th...
Eligibility Criteria
Inclusion
- Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota
Exclusion
- Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant
- Pediatric patients (\<18 years of age)
- Multi-organ transplants (e.g., kidney-pancreas, kidney-liver)
- ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.)
- Patients with severe hyperlipidemia (serum cholesterol \>350 mg/dl or serum triglycerides \>500 mg/dl
- Patients with severe leukopenia (White Blood Cell count \[WBC\]\<3000 10\^3/ml)
- Patients unwilling to return to the transplant center for late follow-up visits
- Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00275535
Start Date
April 1 2001
End Date
December 1 2008
Last Update
December 8 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905