The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: Genzyme, a Sanofi Company; Roche Pharma AG; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Antilymphocyte Serum; Calcineurin Inhibitors; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Sirolimus; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota

Exclusion Criteria:

• 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