Tacrolimus After rATG and Infliximab Induction Immunosuppression-RIMINI Trial.

Autor:	Viklicky O; Department of Nephrology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.; Transplant Laboratory, Institute for Clinical and Experimental Medicine, Prague, Czech Republic., Zahradka I; Department of Nephrology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic., Bold G; Department of Nephrology and Intensive Care, Charité Universitätsmedizin Berlin, Berlin Center for Advanced Therapies (BeCAT), Berlin Institut of Health Center of Regenerative Therapies (BCRT), Berlin Institute of Health, Berlin, Germany., Bestard O; Department of Nephrology and Kidney Transplantation, Vall d'Hebron University Hospital, Barcelona Hospital Campus, Barcelona, Spain.; Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona, Spain., Hruba P; Transplant Laboratory, Institute for Clinical and Experimental Medicine, Prague, Czech Republic., Otto NM; Department of Nephrology and Intensive Care, Charité Universitätsmedizin Berlin, Berlin Center for Advanced Therapies (BeCAT), Berlin Institut of Health Center of Regenerative Therapies (BCRT), Berlin Institute of Health, Berlin, Germany., Stein M; Department of Nephrology and Intensive Care, Charité Universitätsmedizin Berlin, Berlin Center for Advanced Therapies (BeCAT), Berlin Institut of Health Center of Regenerative Therapies (BCRT), Berlin Institute of Health, Berlin, Germany., Sefrin A; Department of Nephrology and Intensive Care, Charité Universitätsmedizin Berlin, Berlin Center for Advanced Therapies (BeCAT), Berlin Institut of Health Center of Regenerative Therapies (BCRT), Berlin Institute of Health, Berlin, Germany., Modos I; Information Technology Department, Institute for Clinical and Experimental Medicine, Prague, Czech Republic., Meneghini M; Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona, Spain., Crespo E; Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona, Spain., Grinyo J; Department of Medicine, Barcelona University, Barcelona, Spain., Volk HD; Berlin Center for Advanced Therapies (BeCAT) and Institute of Medical Immunology, Charité Universitätsmedizin Berlin, Berlin Institut of Health Center of Regenerative Therapies (BCRT), Berlin Institute of Health, Berlin, Germany., Christakoudi S; Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, St. Mary's Campus, Norfolk Place, London, United Kingdom.; Department of Inflammation Biology, School of Immunology and Microbial Sciences, King's College London, London, United Kingdom., Reinke P; Department of Nephrology and Intensive Care, Charité Universitätsmedizin Berlin, Berlin Center for Advanced Therapies (BeCAT), Berlin Institut of Health Center of Regenerative Therapies (BCRT), Berlin Institute of Health, Berlin, Germany.
Jazyk:	angličtina
Zdroj:	Transplantation [Transplantation] 2024 Jan 01; Vol. 108 (1), pp. 242-251. Date of Electronic Publication: 2023 Aug 01.
DOI:	10.1097/TP.0000000000004736
Abstrakt:	Background: Infliximab selectively targets recently activated effector cells and, as an induction agent, might enable the safe elimination of mycophenolate from maintenance immunosuppression in kidney transplantation. Methods: This is a phase II international multicenter open-label single-arm confidence interval (CI)-based clinical trial of the BIO-DrIM EU consortium aimed at assessing the efficacy and safety of rabbit antithymocyte globulin and infliximab induction in kidney transplantation. Sixty-seven primary kidney transplant recipients at low risk (panel-reactive antibodies <20%, no donor-specific antibodies [DSA]) received rabbit antithymocyte globulin (2 × 1.5 mg/kg, postoperative days 0 and 1) and infliximab (5 mg/kg, postoperative day 2), followed by mycophenolate-free tacrolimus-based immunosuppression for 12 mo. The primary endpoint was efficacy failure, defined as a composite of acute rejection, graft loss, or poor graft function (estimated glomerular filtration rate <40 mL/min) at 12 mo and was based on the endpoint of the comparator study. Additionally, a historical propensity-matched control cohort was established. Results: Primary endpoint occurred in 22 of 67 patients (32.84%), with upper bound of an exact 1-sided 95% CI of 43.47%, which met the predefined criteria (efficacy failure of <40% and upper-bound 95% CI of <50%) and was similar in the historical matched cohort. By 12 mo, 79.1% of patients remained on the study protocol. Lower rates of BK replication (6% versus 22.4%; P  = 0.013) but higher rates of de novo DSAs (11.9% versus 1.5%; P  = 0.039) were observed in the study cohort. Conclusions: A similar efficacy of the study immunosuppression regimen to the comparator study and the historical matched cohort was found. However, a higher de novo DSA emergence points to an increased risk of antibody-mediated rejection (NCT04114188). Competing Interests: The authors declare no conflicts of interest. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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