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Tacrolimus‐ versus sirolimus‐based immunosuppression after simultaneous pancreas and kidney transplantation: 5‐year results of a randomized trial
Author(s) -
Cantarovich Diego,
Kervella Delphine,
Karam Georges,
Dantal Jacques,
Blancho Gilles,
Giral Magali,
Garandeau Claire,
Houzet Aurélie,
Ville Simon,
Branchereau Julien,
Delbos Florent,
GuillotGueguen Cécile,
Volteau Christelle,
Leroy Maxime,
Renaudin Karine,
Soulillou JeanPaul,
Hourmant Maryvonne
Publication year - 2020
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.15809
Subject(s) - medicine , tacrolimus , sirolimus , immunosuppression , urology , transplantation , kidney transplantation , surgery , interim analysis , clinical endpoint , protein synthesis inhibitor , discontinuation , randomized controlled trial , gastroenterology , antibacterial agent , antibiotics , microbiology and biotechnology , biology
Tacrolimus, the cornerstone immunosuppression after simultaneous pancreas and ‐kidney (SPK) transplantation, may exert nephrotoxic and diabetogenic effects. We therefore prospectively compared in an open‐label, randomized, monocentric, 5‐year follow‐up study, a tacrolimus‐ and a sirolimus‐based immunosuppressive regimen. Randomization using the block method allowing a blind allocation was done at the time of surgery. All patients received anti‐thymocyte globulin and maintenance therapy with tacrolimus, mycophenolate mofetil, and steroids. At month 3, tacrolimus was continued or replaced by sirolimus. The primary endpoint was kidney and pancreas graft survival at 1 and 5 years. Fifty patients were included in the final analysis in each group. At 1 year, differences for kidney and pancreas graft survival between sirolimus and tacrolimus were 0% (90% confidence interval −4.61% to 4.61%) and 6% (90% confidence interval −6.32% to 18.32%), respectively. There was no difference in renal and pancreas graft survival at 5 years. Thirty‐four patients (68%) in the sirolimus group vs three (6%) in the tacrolimus group needed definitive withdrawal of the study drug. Despite noninferiority of sirolimus compared to tacrolimus for kidney and pancreas graft survival, the high rate of sirolimus discontinuation does not favor its use as cornerstone therapy after SPK transplantation (NCT00693446).