Reduced rate of acute rejection with rapamycin vs. mycyphonolate mofetil in simultaneous pancreas kidney (SPK) recipients. Randomized, prospective trial at 10 years

G. Ciancio¹, J. Sageshima¹, L. Chen¹, J. Gaynor¹, L. Hanson¹, L. Tueros¹, D. Roth², W. Kupin², G. Guerra², A. Mattiazzi², A. Pugliese³, G. Burke^1
1 University of Miami, Surgery, Miami, USA; ² University of Miami, Nephrology, Miami, USA; ³ Diabetes Research Institute, University of Miami, Miami, USA

Objective: To assess efficacy and safety of rapamycin (Rapa) and mycophenolate mofetil (MMF) in long term, prospective randomized trial in SPK recipients.

Methods: From September 2000 through September 2009, 170 patients with type 1 diabetes and end stage renal disease were enrolled in a randomized, prospective, single center immunosuppression study. Patients were randomized to receive MMF (1 gm BID) or Rapa (4 mg/day, target level 5-7). All patients received daclizumab (1 mg/kg x 2 doses) and thymoglobulin (1 mg/kg x 5 doses) induction, and tacrolimus (target level 5-7) and steroid maintenance immunosuppression. All pancreas transplants were bladder (exocrine) and systemic venous (endocrine) drained.

Results: The rate of freedom from acute rejection during the first year for kidney and/or pancreas, either clinically suspected or biopsy proven was statistically significant better for Rapa vs. MMF (overall 88±4% vs. 66±5%, p<0.02). There was no difference in creatinine, hemoglobin A1C, viral infections (CMV, polyoma, EBV), lymphoproliferative disorders, reoperation, post transplant diabetes, lipid profile or percentage of patients receiving statins, weight gain, or proteinuria at 96 months between groups. Comparing Rapa vs MMF at 96 months, there were comparable patient survival (78±6% vs 78±5%), death-censored pancreas (98±2% vs 90±4) and kidney graft survival (77±7% vs. 74±6%).

Conclusions: In a long-term, randomized, prospective, single center study, Rapa was found to be more effective than MMF from the standpoint of reducing the rate of acute rejection for both kidney and pancreas allografts. Nonetheless, long-term survival results were comparable in both groups.