The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
- Conditions
- Kidney Diseases
- Interventions
- Registration Number
- NCT00275535
- Lead Sponsor
- Mayo Clinic
- 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. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus Anti-thymocyte globulin Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone. Tacrolimus Prednisone Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone. Sirolimus Anti-thymocyte globulin Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone. Sirolimus Mycophenolate mofetil Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone. Sirolimus Sirolimus Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone. Tacrolimus Mycophenolate mofetil Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone. Tacrolimus Tacrolimus Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone. Sirolimus Prednisone Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
- Primary Outcome Measures
Name Time Method Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation 12 months following transplantation Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.
- Secondary Outcome Measures
Name Time Method GFR (iothalamate clearance) at other time points 24 months Other measures of renal function (serum creatinine, proteinuria and albuminuria) 24 months Acute rejection both early and after tacrolimus withdrawal 24 months Patient and graft survival 24 months after transplantation Complications-especially hypertension, diabetes, dyslipidemia 24 months
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States