P859 Introduction: New onset post-transplant diabetes mellitus (PTDM) has become increasingly recognized complication of kidney transplantation. Albeit, in the majority of studies during the past decade PTDM rate was found to be significantly higher among patients receiving tacrolimus than cyclosporine, there are major center differences in the reported incidence of PTDM as well as controversy as to the extent of diabetogenicity of tacrolimus (Tac) vs. cyclosporine (Csa). Aim: In this study, we aimed to determine the incidence and dynamics of PTDM in a cohort of consecutive renal transplant recipients remaining on Csa or switched to Tac and followed up for 5 years. Methods: We studied records of all consecutive renal graft recipients (n 107), excluding those with pretransplant diabetes mellitus, transplanted in 1998 and followed up throughout 1998-2003 for new onset of PTDM, defined as de-novo hyperglycemia (glucose >120 mg/dL) treated for more than 1 month. The posttransplant immunosuppression consisted of Csa (Neoral) – started at 10 mg/kg and adjusted to blood levels of 300ng/ml (0-3 mos), 200-250 ng/ml (3-6 mos), 150-200 ng/ml (6-12 mos), 100-150 ng/ml (> 12 mos) or Tac- started at 0.15 mg/kg and adjusted to blood levels of 15-20 ng/ml (0-1 mos), 10-15 ng/ml (1-6 mos), 5-10 ng/ml (>6 mos) given in conjunction with prednisone - 500 mg/d of solumedrol, followed by prednisone 100 mg/d >30 mg/d > 20 mg/d > 10 mg/d tapering over 6 months, azathioprine – at 150 mg/d, or replaced by mycophenolate mofetil - 1.0-2.0 gr/d. The patients were divided into 2 groups: those remaining on Csa (n 43) and those started (n 19) or switched to Tac (n 45). Patient demographics, PRA, HLA match, donor organ parameters, incidence of PTDM, graft and patient survival, and renal function in patients on Csa (Neoral) and Tac were compared, when appropriate, by Wilcoxon Two-Sample, Chi-Square, Fisher’s Exact, T test, Gehan-Wilcoxon, Cox-Mantel, Log rank and Kaplan-Meier tests (SAS statistical software). Results: PTDM was detected in 12/107 patients (11.2%). At the time of its appearance, PTDM prevalence in patients under Tac and Csa -5/50 (10%) and 7/57 (12.2%), respectively was not significantly different (Fisher, Chi test NS). Highest prevalence of new PTDM cases was observed in the first post-transplant year – 11/12 cases (91.7%). In contrast to some previous reports, mellow slope of the PTDM increase was observed on predominantly low-dose FK based protocol after the first year, with the calculated annual elevation of 0.25% in the posttransplant years 2-5. Conclusions: Our results show the PTDM cumulative 5 year incidence of 11.2%. No significant difference in PTDM incidence was found between Csa and Tac treatment (12.2% and 10% over 5 years, respectively). Therefore, it appears that in comparison with Csa immunosuppression, our current, tacrolimus-based protocol is not associated with the increased incidence of PTDM.
P757 Aims: Five doses of daclizumab given initially after kidney transplantation have been shown to reduce acute rejection (AR). Most previous studies with daclizumab were performed mainly in cyclosporine treated recipients and only few were done in patients on tacrolimus-based protocol. The aim of this study was to determine the safety and efficacy of two doses of daclizumab combined with tacrolimus (Tac), mycophenolate mofetil (MMF) and corticosteroids (CS) in prevention of acute rejection in primary kidney allograft. Methods: 25 patients were recruited and randomized into induction (n=11) and control (n=14) groups. All patients received initially 0.15mg/kg of Tac tapered to 0.1mg/kg (mean blood levels 10.9 +/− 2.5 ng/dL at first 3 months, 9.5 +/− 2,9 ng/dL at 6 months and 7.9+/− 2.0 ng/dL at one year), MMF at 2gr/bw/day and CS tapered from 100 to 10 mg/bw/day at 6 month. The induction group received two doses of 1mg/kg daclizumab: before engraftment and on postoperative day 14. All patients received CMV prophylaxis with oral gancyclovir. Patient demographics, PRA status and donor organ characteristics were not significantly different between induction and study group. The mean follow up was 16.8 +/− 4,3 months. Fisher Exact and Student T tests were used as appropriate to compare groups. Results: At one year, biopsy proven AR was diagnosed in 5/14 (35%) of control patients not receiving daclizumab and in none of patients with induction (0/11, 0%) (p 0.05). One patient from control group died from cardiac infarction with functioning renal graft. Delayed graft function, defined as absence of spontaneous reduction of creatinine requiring dialysis support, occurred in 6 out of 14 patients (42.8%) from the control group and in 3/11 (27%) patients treated with daclizumab, p NS. Mean creatinine at one year was 1.47+/−0.8 mg/dL in induction and 1.55+/−0.9 mg/dL in control group (NS), the non censored one year patient and graft survival was 100%/100% and 92.8%/ 85.7% (NS) in daclizumab and control group respectively. There were no adverse effects related to daclizumab administration. The infectious complications (UTI and wound infections) occurred in 5/11 and 9/14 (NS) patients from induction and control groups respectively. Conclusions: Our data suggest that the two doses of daclizumab combined with tacrolimus-MMF-CS protocol is effective in preventing acute rejection, reducing incidence of delayed graft function rate and in maintaining satisfactory graft function. The additional advantages of limited dose daclizumab-tacrolimus combination protocol, could be it’s cost effectiveness as well as lesser likelihood of development of neutralizing anti-daclizumab antibodies.