CLINICAL IMMUNOSUPPRESSION - KIDNEY EARLY

H.P. Arbogast¹, M. Guba², M. Stangl³, M. Fischereder⁴, K. Jauch^2
1Department Of Surgery, University of Munich - Grosshadern Medical Centre, Munich/GERMANY, ²Department Of Surgery, University of Munich, Munich/GERMANY, ³Dept. Of Surgery, Ludwig-Maximilians-University, Munich/GERMANY, ⁴Medizinische Poliklinik Innenstadt, Klinkum der Ludwig-Maximilian-Universität, München, Munich/GERMANY

Body: Introduction: For the past 30 years, renal transplantation has advanced to the standard treatment of end-stage renal disease. Due to the limited graft survival, however, an increasing number of renal transplant patients present for second, third, even fourth transplant, frequently with an increased panel reactivity (PRA). Literature and own observations demonstrate significantly lower graft survival (GS) rates, compared to non-sensitized patients undergoing first transplant. This study examines the efficacy and safety of a combined polyclonal-monoclonal induction ("Pumuckl"), in high-risk cadaveric renal transplantation. Patients and Methods: 70 consecutive transplant recipients (38 male and 32 female, mean age 44.5y) of a repeat (second/third/fourth) renal transplant and/or with a PRA>30%, were enroled in this study and were followed for a period of up to 4 years. Follow-up assessments were performed at 1, 3, 6 and 12 months, 2, 3 and 4 years. Besides GS, the assessment included functional parameters, as well as adverse events, complications and graft loss. All patients received an induction therapy with a combination of a single-shot low-dose ATG bolus, perioperatively and Basiliximab (d0 and d4). Maintenance immunosuppression was performed with a combination of tacrolimus, MMF and steroids. Results were compared to a historical control of high-risk renal transplant patients, receiving a 7-day induction with ATG. Results: Patient survival at 12 months (2/4 years) was 100(100/100)%. Over all, 1-(2-/4-)year GS was 88.6(88.6/77.8)%. Only 3 grafts were lost due to technical problems (sepsis, graft vein thrombosis), only 4 graft losses accounted for immunological reasons. During the first year, the number of biopsy-proven acute rejection episodes (ARE) was 25%. Delayed graft function (DGF) was found in 15/70 patients (21.4%). 2 patients had to be discontinued from the study medication and were converted to a different immunosuppressive protocol (CsA/MMF due to PTDM and Sirolimus/MMF due to CNI nephrotoxicity). In 3 patients, MMF had to be discontinued due to chronic diarrhea. At 1y, mean tacrolimus serum levels were 8.22ng/ml. Serum creatinine values at 1y presented acceptable at a mean of 1.53mg/dl. Other adverse events did not differ significantly from the low-risk renal transplant recipient population. Conclusion: We conclude that a combined induction therapy with single-shot ATG and Basiliximab, in combination with a maintenance therapy with tacrolimus, MMF and steroids, provides a very effective and safe regimen in a high-risk renal transplantation collective.

Disclosure: All authors have declared no conflicts of interest.