PMID- 15814544 OWN - NLM STAT- MEDLINE DCOM- 20050901 LR - 20131121 IS - 0931-0509 (Print) IS - 0931-0509 (Linking) VI - 20 Suppl 2 DP - 2005 May TI - Rejection after simultaneous pancreas-kidney transplantation. PG - ii11-7, ii62 AB - BACKGROUND: Simultaneous pancreas-kidney (SPK) transplantation is an accepted therapy for type 1 diabetic patients with end-stage renal disease. This study analyses the occurrence of rejection episodes in patients undergoing SPK. METHODS: The study population was obtained from 205 patients enrolled in the Euro-SPK 001 study and randomized to receive tacrolimus- (n = 103) or cyclosporin microemulsion (ME)-based (n = 102) immunosuppressive therapy. All patients received concomitant antibody induction therapy, mycophenolate mofetil and short-term corticosteroids. RESULTS: After 3 years of follow-up, rejection episodes occurred in 41 patients receiving tacrolimus and in 51 patients receiving cyclosporin-ME. The majority of first rejection episodes in both groups occurred during the first 6 months (93 and 90%, respectively) and in most cases were treated with corticosteroids alone (88 vs 90%). Actuarial rejection-free kidney and/or pancreas graft survival was similar for tacrolimus (54%) and cyclosporin-ME (44%). Human leukocyte antigen (HLA) compatibility (P = 0.003) and graft vessel extension (P = 0.000001) had a significant influence on rejection-free graft survival. Also, rejection influenced pancreas graft survival (P = 0.01), and pancreas graft loss due to rejection influenced patient survival (P = 0.02). In the intent-to-treat analysis of early rejection, significantly fewer tacrolimus- than cyclosporin-ME-treated patients had (i) more than one rejection episode (11 out of 40 vs 24 out of 47; P = 0.03); (ii) first moderate to severe rejection (one out of 40 vs 12 out of 47; P = 0.004); and (iii) refractory rejection (two out of 40 vs 10 out of 47; P = 0.03). Pancreas survival was lower in late rejectors (53%) than non-rejectors (86%; P = 0.002). Also, serum creatinine was highest in late rejectors. CONCLUSION: Tacrolimus-based immunosuppressive therapy demonstrates significant advantages over cyclosporin-ME in terms of the severity of acute rejection in SPK transplant patients. FAU - Arbogast, Helmut AU - Arbogast H AD - Department of Surgery, University of Munich, Grosshadern, Marchioninistr. 15, D-81377 Munich, Germany. helmut.arbogast@med.uni-muenchen.de FAU - Malaise, Jacques AU - Malaise J FAU - Illner, Wolf-Dieter AU - Illner WD FAU - Tarabichi, Anwar AU - Tarabichi A FAU - Dieterle, Christoph AU - Dieterle C FAU - Landgraf, Rudiger AU - Landgraf R FAU - Land, Walter AU - Land W CN - Euro-SPK Study Group LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Nephrol Dial Transplant JT - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JID - 8706402 RN - 0 (Emulsions) RN - 0 (Immunosuppressive Agents) RN - 83HN0GTJ6D (Cyclosporine) RN - WM0HAQ4WNM (Tacrolimus) SB - IM MH - Adolescent MH - Adult MH - Biopsy MH - Cyclosporine/therapeutic use MH - Diabetes Mellitus, Type 1/complications/*surgery MH - Diabetic Nephropathies/complications/surgery MH - Disease-Free Survival MH - Drug Therapy, Combination MH - Emulsions MH - Female MH - Follow-Up Studies MH - Graft Rejection/epidemiology/pathology/*prevention & control MH - Graft Survival MH - Humans MH - Immunosuppressive Agents/therapeutic use MH - Incidence MH - Kidney Failure, Chronic/etiology/*surgery MH - *Kidney Transplantation MH - Male MH - Middle Aged MH - *Pancreas Transplantation MH - Postoperative Complications MH - Tacrolimus/therapeutic use EDAT- 2005/04/09 09:00 MHDA- 2005/09/02 09:00 CRDT- 2005/04/09 09:00 PHST- 2005/04/09 09:00 [pubmed] PHST- 2005/09/02 09:00 [medline] PHST- 2005/04/09 09:00 [entrez] AID - 20/suppl_2/ii11 [pii] AID - 10.1093/ndt/gfh1077 [doi] PST - ppublish SO - Nephrol Dial Transplant. 2005 May;20 Suppl 2:ii11-7, ii62. doi: 10.1093/ndt/gfh1077.