THE CLINICAL STUDY OF IMMUNOSUPPRESSION PROTOCOL IN ABO-INCOMPATIBLE KIDNEY TRANSPLANTATION.
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major infection episode, lymphocele and deep venous thrombosis occurred in each group. No CMV infection was observed. One patient in each group needed simvastatin. Average daily Cy doses to achieve the target BL were 6.1, 2.2 and 2.0 mg/ Kg at month 1, 2 and 4, respectively in Ev group and, 5.4, 4.0 and 2.9 mg/ Kg in Az group. Average Ev doses at the same periods were 0.55, 0.75 and 0.75 mg/d. Other variables are shown in table 1. Everolimus Azathioprine p Creatinine clearance month 1 66 + 21 63 + 20 0.69 Creatinine clearance month 2 71 + 18 69 + 19 0.73 Creatinine clearance month 4 62 + 15 72 + 24 0.38 Total cholesterol (mg/dl) 230 + 52 207 + 34 0.24 Triglycerides (mg/dL) 259 + 123 189 + 91 0.15 The combination of Cy, K, steroids and Ev is as effective and safe as Cy, K, steroids and Az. Because of the small cohort, it was not possible to demonstrate immunological superiority of the Ev scheme. Longer follow up is required to evaluate renal function and patient and renal survival. Abstract# 1310 Poster Board #-Session: P105-I 1310 Poster Board #-Session: P105-I THE CLINICAL STUDY OF IMMUNOSUPPRESSION PROTOCOL IN ABO-INCOMPATIBLE KIDNEY TRANSPLANTATION. Yuki Nakagawa, Kazuhide Saito, Kota Takahasi. Division of Urology, Department of Regenerative and Transplant Medicine, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan. Background: Immunosuppression therapy for ABO-incompatible kidney transplantations have previously been more rigorously practiced than ABOcompatible. However, we found that patients treated with this regimen developed a high rate of complications. In our search for optimal immunosuppression, we have evolved and made three major changes in the induction period immunosuppressive therapy in ABO-incompatible kidney transplantation. We have been comparable with three induction period immunosuppressive therapy. Methods: Thirty kidney recipients were enrolled in our study comparing the three protocols. GroupI(n=13) patients received a standard immunosupressants (cyclosporine or tacrolimus, azathioprine or CPA, and a standard-dose steroid with splenectomy during April, 1996-March, 2002. Group II (n=6) patients were treated with a low-dose calcineurin-inhibitor with MMF, and an early low-dose steroid and induction with Basiliximab and splenectomy during April, 2002-August, 2004. Group III (n=11) patients were treated with a low-dose calcineurin-inhibitor with MMF, an early low-dose steroid and Basiliximab induction with Rituximab without splenectomy during September, 2004-December, 2005. Results: Patient (93%versus 100%, 100%) and graft survival (84.6% versus 66.6%, 90.9%) at 1year were no different between the groups. Patients of Group IIIexperienced significantly less acute rejections than those in Group I (77% versus 36.3%, P=0.04). Allograft function and incidence of adverse events and infections were similar between the three groups. However the early low-dose steroid protocol Groups( GII and GIII ) patients experienced significantly less peptic ulcer and PTDM (post-transplant DM ). Conclusion: We have be able to improve graft survival and reduced complications, through we have evolved in the induction period immunosuppressive therapy in ABO-incompatible kidney transplantation. Abstract# 1311 Poster Board #-Session: P106-I CALCINEURIN INHIBITOR FREE IMMUNOSUPPRESSION IN KIDNEY TRANSPLANTATION FROM VERY ELDERLY DONORS. Fabio Vistoli, Ugo Boggi, Marco Del Chiaro, Stefano Signori, Chiara Croce, Irene Mosca, Francesco Sgambelluri, Piero Marchetti, Massimiliano Barsotti, Gaetano Rizzo, Franco Mosca. Kidney Transplantation Center, University of Pisa, Pisa, Italy. Introduction. Ageing increases kidney susceptibility to nephrotoxicity of calcineurin inhibitors (CNI). We compared the efficacy and safety profiles of a CNI-free (CNI-F) and a CNI-based (CNI-B) regimen in kidney transplantation (KTx) from very elderly donors. Methods. From April 2001 to January 2006, 59 first cadaveric KTx were performed in not-immunized recipients, from donors aged 65 years or more. All the recipients received induction with basiliximab and steroids, plus maintenance with low dose steroids and MMF. Twenty-eight patients (10 single and 18 dual-KTx), were managed according to a CNI-F regimen based on delayed rapamycin introduction, 7 days after KTx or when creatinine fall below 2.5 mg/dl, to maintain a trough level of 10-15 ng/dl. The others 31 recipients (17 single and 14 dual-KTx) were managed in a CNI-B regimen, with Neoral(n=26) or Prograf(n=5) delayed introduction, 7 days after KTx or when creatinine fall below 2.5 mg/dl. All the recipients received basiliximab, low dose steroids and mycophenolate mofetil (MMF) dose was tailored according to mycophenolic acid through levels. Results. Three recipients died: 2 (CNI-B) perioperatively and 1 (CNI-F) after 6 months. Delayed graft function occurred in 18 (30.5%) patients (14 CNI-B vs. 4 CNI-F; p=0.01). Mean MMF dose was 1.3 g/day in CNI-F group vs 1.8 g/day in CNI-B group. Overall, acute rejection rate was 10.2% (9.7% CNI-B vs. 10.7% CNI-F). No patient was dropped from the assigned immunosuppressive regimen. One-year mean creatinine level was 1.2 (CNIF) vs. 1.4 (CNI-B) mg/dl (p=0.06). Early and long term complications were equivalent in the two groups but statin therapy that was required only in CNI-F (n=21; 75.0%) (p<0.0001). Four-year patient and graft survival rates were both 96.1% in CNI-F, and 93.3% and 89.3% in CNI-B, respectively. Conclusions. CNI-F immunosuppression is a valid alternative to CNI-B regimens in KTx from very elderly donors. Abstract# 1312 Poster Board #-Session: P107-I 1312 Poster Board #-Session: P107-I THERAPEUTIC DRUG MONITORING OF MYCOPHENOLIC ACID CAN BE USED AS PREDICTOR OF CLINICAL EVENTS FOR KIJNEY TRANSPLANT RECIPIENTS TREATED WITH MYCOPHENOLATE MOFETIL. Yi Ping Lu, Yu Chun Zhu, Mao Zhi Liang, Fen Nan, Qun Yu, You Ping Li. Transplantation Institute, West China Hospital, Sichuan University, Chengdu, Sichuan, China; Department of Clinical Pharmacology, West China Hospital, Sichuan University, Chengdu, China. Objective This study was designed to investigate the relationship between the clinical events and the pharmacokinetics of mycophenolic acid (MPA) in adult renal transplant patients. Methods Thirty-seven adult kidney transplant recipients were included in the study. All patients received a triple therapy of CsA, MMF and steroids. MPA-AUC0-12 was obtained before and 12 days after grafting by RPHPLC. Predose blood samples were gathered from all the recipients at 4th, 12th, 21st days and 1, 1.5, 2, 2.5, 3 and 6 months after grafting and MPA-C0 was measured. The clinical events at corresponding time points were observed and recorded intently. Each MPA-C0 value together with its corresponding clinical events was looked as a study unit. Results Single-dose and multi-dose MPA-AUC0-12 were obtained. Furthermore, 357 MPA-C0 values were obtained from 37 patients. The 357 units were divided into three sub-groups: Group A, including 239 units (66.9%) had uneventful outcomes, Group B included 100 units (28.0%) presented with MPA-related side effects, and Group C included 18 units (5.0%) experienced acute rejection. MPA-C0 in groups A, B and C was 0.8416±0.1373 mg/L, 1.5903±0.3741 mg/L and 0.6057±0.2338 mg/L, respectively (P<0.001 between group A and B, group B and C, and P=0.021 between group A and C). The 3 groups were also divided into initial phase (≤1 month, 251 units) and stable phase (>1 month, 106 units), the relationship between MPA-C0 and the associated clinical events was also investigated.