Abstract
Introduction: Although prone to a higher degree of ischemia reperfusion injury (IRI), the use of extended criteria donor (ECD) organs has become reality in transplantation. We therefore postulated that peri-operative perfusion of renal transplants with anti-human T-lymphocyte globulin (ATLG) ameliorates IRI and results in improved graft function.Methods: We performed a randomized, single-blinded, placebo-controlled trial involving 50 kidneys (KTx). Prior to implantation organs were perfused and incubated with ATLG (AP) (n = 24 kidney). Control organs (CP) were perfused with saline only (n = 26 kidney). Primary endpoint was defined as graft function reflected by serum creatinine at day 7 post transplantation (post-tx).Results: AP-KTx recipients illustrated significantly better graft function at day 7 post-tx as reflected by lower creatinine levels, whereas no treatment effect was observed after 12 months surveillance. During the early hospitalization phase, 16 of the 26 CP-KTx patients required dialysis during the first 7 days post-tx, whereas only 10 of the 24 AP-KTx patients underwent dialysis. No treatment-specific differences were detected for various lymphocytes subsets in the peripheral blood of patients. Additionally, mRNA analysis of 0-h biopsies post incubation with ATLG revealed no changes of intragraft inflammatory expression patterns between AP and CP organs.Conclusion: We here present the first clinical study on peri-operative organ perfusion with ATLG illustrating improved graft function in the early period post kidney transplantation.Clinical Trial Registration: www.ClinicalTrials.gov, NCT03377283
Highlights
Prone to a higher degree of ischemia reperfusion injury (IRI), the use of extended criteria donor (ECD) organs has become reality in transplantation
24 subjects were randomly allocated to receive a kidney transplant perfused with anti-human T-lymphocyte globulin (ATLG) and 26 patients were randomly allocated to receive a kidney transplant perfused with saline only
Whereas only ten of the 24 patients in the ATLG group developed delayed graft function (DGF), 16 of the 26 control patients were diagnosed with DGF (41.6 vs. 61.5%; p = 0.257)
Summary
Prone to a higher degree of ischemia reperfusion injury (IRI), the use of extended criteria donor (ECD) organs has become reality in transplantation. We postulated that peri-operative perfusion of renal transplants with anti-human T-lymphocyte globulin (ATLG) ameliorates IRI and results in improved graft function. The growing demand for solid organs parallel with the decreasing number of potential donors has led to the use of organs derived from extended criteria donors (ECD) or organs retrieved after circulatory death (DCD) [1] These organs show a higher risk for unfavorable outcome as they are more susceptible to ischemia reperfusion injury (IRI) [2, 3]. As we and others have already illustrated that rATG induction therapy is a safe and reasonable approach in liver transplantation [22, 23], we explored the potential for perfusing donor kidneys peri-operatively with ATLG in order to ameliorate
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