Long-term Prolonged-release Tacrolimus-based Immunosuppression in De Novo Kidney Transplant Recipients: 5-Y Prospective Follow-up of Patients in the ADVANCE Study.

Autor:	Pernin V; Department of Nephrology, Dialysis and Transplantation, Hôpital Lapeyronie, University of Montpellier, Montpellier, France., Glyda M; Department of Transplantology and Surgery, District Public Hospital Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Bydgoszcz, Poland., Viklický O; Department of Nephrology, Transplant Center, Institute for Clinical and Experimental Medicine, Prague, Czech Republic., Lõhmus A; Department of Urology and Kidney Transplantation, Clinic of Surgery, Tartu University Hospital, Tartu, Estonia., Wennberg L; Department of Transplantation Surgery, Karolinska University Hospital, Stockholm, Sweden., Witzke O; Department of Infectious Diseases, West German Centre of Infectious Diseases, University Hospital Essen, University Duisberg-Essen, Germany., von Zur-Mühlen B; Department of Surgical Sciences, Division of Transplantation Surgery, Uppsala University Hospital, Uppsala, Sweden., Anaokar S; Medical Affairs, Astellas Pharma Europe, Chertsey, United Kingdom., Hurst M; Medical Affairs, Astellas Pharma Europe, Chertsey, United Kingdom., Kazeem G; Medical Affairs, Astellas Pharma Europe, Chertsey, United Kingdom.; BENKAZ Consulting Ltd, Cambridge, United Kingdom., Undre N; Medical Affairs, Astellas Pharma Europe, Chertsey, United Kingdom., Kuypers DRJ; Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium.
Jazyk:	angličtina
Zdroj:	Transplantation direct [Transplant Direct] 2023 Feb 08; Vol. 9 (3), pp. e1432. Date of Electronic Publication: 2023 Feb 08 (Print Publication: 2023).
DOI:	10.1097/TXD.0000000000001432
Abstrakt:	Although prolonged-release tacrolimus (PR-T) is widely approved for posttransplantation immunosuppression in kidney recipients, large-scale studies are required to assess long-term outcomes. We present follow-up data from the Advagraf-based Immunosuppression Regimen Examining New Onset Diabetes Mellitus in Kidney Transplant Recipients (ADVANCE) trial, in which kidney transplant patients (KTPs) received corticosteroid minimization with PR-T. Methods: ADVANCE was a 24-wk, randomized, open-label, phase-4 study. De novo KTPs received PR-T with basiliximab and mycophenolate mofetil and were randomized to receive an intraoperative corticosteroid bolus plus tapered corticosteroids until day 10 (arm 1) or an intraoperative corticosteroid bolus (arm 2). In this 5-y, noninterventional follow-up, patients received maintenance immunosuppression according to standard practice. The primary endpoint was graft survival (Kaplan-Meier). Secondary endpoints included patient survival, biopsy-confirmed acute rejection-free survival, and estimated glomerular filtration rate (4-variable modification of diet in renal disease). Results: Follow-up study included 1125 patients. Overall graft survival at 1 and 5 y posttransplantation was 93.8% and 88.1%, respectively, and was similar between treatment arms. At 1 and 5 y, patient survival was 97.8% and 94.4%, respectively. Five-year graft and patient survival rates in KTPs who remained on PR-T were 91.5% and 98.2%, respectively. Cox proportional hazards analysis demonstrated similar risk of graft loss and death between treatment arms. Five-year biopsy-confirmed acute rejection-free survival was 84.1%. Mean ± standard deviation values of estimated glomerular filtration rate were 52.7 ± 19.5 and 51.1 ± 22.4 mL/min/1.73 m 2 at 1 and 5 y, respectively. Fifty adverse drug reactions were recorded, probably tacrolimus-related in 12 patients (1.5%). Conclusions: Graft survival and patient survival (overall and for KTPs who remained on PR-T) were numerically high and similar between treatment arms at 5 y posttransplantation. Competing Interests: All authors report nonfinancial support from Astellas during the conduct of the study. O.W. has received research grants for clinical studies, speaker’s fees, honoraria, and travel expenses from Amgen, Astellas, Bristol-Myers Squibb, Chiesi, Janssen-Cilag, MSD, Novartis, Roche, Pfizer, and Sanofi. O.W. is also supported by an unrestricted grant of the Rudolf-Ackermann-Stiftung (Stiftung für Klinische Infektiologie). S.A., M.H., and N.U. are employed by Astellas. G.K. is a consultant statistician working on behalf of Astellas who has also received support for travel from Astellas. D.R.J.K. has received research grants, speaker’s fees, honoraria, and travel grants from Astellas. (Copyright © 2023 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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