Introduction. Minimizing or sparing potentially nephrotoxic and diabetogenic immunosuppressants could represent an advantage following simultaneous pancreas-kidney transplantation (SPK-Tx).
Purpose. We report here the actual one-year result of a single-center, phase IV study, initiated in 2005, prospectively and randomly evaluating the efficacy and safety of tacrolimus-based (Tac) against sirolimus-based (SRL) immunosuppresssion after SPK-Tx.
Methods. A total of 100 type-1 diabetic patients (mean age 40 years; range 21-56) were included in the study BRD 04/2D, after written informed consent was obtained. All patients received a cadaver SPK-Tx (whole pancreas with portal and enteric drainages) and were randomly assigned (double-blinded) at the time of Tx to continue Tac (n=50; mean age 40.5 years) or to replace Tac by SRL (n=50; mean age 39.4 years) 60-90 days after surgery. Immunosuppression consisted of Thymoglobulin induction for 5 days, mycophenolate mofetil, tacrolimus and low-dose steroid (i.e. withdrawn on day 90). The study design included a 1-year protocol kidney biopsy and a follow-up of 5 years.
Results. The 1-year actual patient, pancreas and kidney survival was 100%, 84% and 100% in the Tac group, and 100%, 88% and 100% in the SRL one (intention to treat analyses). The 1-year freedom from clinical diagnosed and treated kidney and pancreas rejection episode was 90% and 96% in the Tac group, and 86% and 86% in the SRL one. Serum creatinine (¯o;mol/L) and proteinuria (gr/day) at one year was 122 (range 61-289) and 0.32 (0-1.03) in the Tac group, and 115 (57-412) and 0.38 (0-1.5) in the SRL one. At this time period, 96% of patients in the Tac group were still under Tac compared to 54% in the SRL one (p<0.001).
|Number of biospsies||30||40|
|Normal||15 (50%)||16 (40%)|
|Borderline||2 (7%)||2 (5%)|
|Cellular rejection||0||2 (5%)|
|Humoral rejection||0||4 (10%)|
|C4d positive||1||4 (10%)|
|Fibrosis grade 1-2||11 (37%)||18 (45%)|
|Fibrosis grade 3||0||0|
Conclusion. At one year following SPK-Tx, Tac-based immunosuppression as compared to SRL-based immunosuppression was better tolerated with significant less number of patients switched and was associated with less acute rejection episodes and less active immune renal histology features.
To cite this abstract in AMA style:Cantarovich D, Papuchon E, Blancho G, Dantal J, Giral M, Branchereau J, Karam G. Prospective and Randomized Trial Comparing Tacrolimus Versus Sirolimus after Simultaneous Pancreas-Kidney Transplantation [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/prospective-and-randomized-trial-comparing-tacrolimus-versus-sirolimus-after-simultaneous-pancreas-kidney-transplantation/. Accessed October 30, 2020.
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