Three-year results of renal function in liver transplant recipients on low-dose sirolimus and tacrolimus: a multicenter, randomized, controlled trial.

Autor:	Mulder MB; Department of Hospital Pharmacy, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.; Department of Epidemiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands., van Hoek B; The Erasmus MC Transplant Institute, Rotterdam, The Netherlands., van den Berg AP; Department of Gastroenterology and Hepatology, LUMC, Leiden University Medical Center, Leiden, The Netherlands., Polak WG; Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Department of Epidemiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands., Alwayn IPJ; Department of Surgery, Division of HPB and Transplant Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands., de Jong KP; Department of Surgery, LUMC, Leiden University Medical Center, Leiden, The Netherlands., de Winter BCM; Department of Hospital Pharmacy, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.; Department of Epidemiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands., Verhey-Hart E; Department of Biostatistics, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.; Department of Epidemiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands., Erler NS; Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands., den Hoed CM; Department of Biostatistics, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.; Department of Epidemiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands., Metselaar HJ; Department of Biostatistics, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.; Department of Epidemiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society [Liver Transpl] 2023 Feb 01; Vol. 29 (2), pp. 184-195. Date of Electronic Publication: 2023 Jan 03.
DOI:	10.1097/LVT.0000000000000003
Abstrakt:	The aim of this study was to investigate whether the combination of low-dose sirolimus (SRL) and low-dose extended-release tacrolimus (TAC) compared to normal-dose extended-release TAC results in a difference in the renal function and comparable rates of rejection, graft and patient survival at 36 months after transplantation. This study was an open-label, multicenter randomized, controlled trial. Patients were randomized to once-daily normal-dose extended-release TAC (control group) or once-daily combination therapy of SRL and low-dose extended-release TAC (interventional group). The primary endpoint was the cumulative incidence of chronic kidney disease (CKD) defined as grade ≥3 (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2) at 36 months after transplantation. In total, 196 patients were included. CKD at 36 months was not different between the control and interventional group (50.8%, 95% CI: 39.7%-59.9%) vs. 43.7%, 95% CI: 32.8%-52.8%). Only at 6 months after transplantation, the eGFR was higher in the interventional group compared to the control group (mean eGFR 73.1±15 vs. 67.6±16 mL/min/1.73 m2, p=0.02) in the intention-to-treat population. No differences in the secondary endpoints and the number of serious adverse events were found between the groups. Once daily low-dose SRL combined with low-dose extended-release TAC does ultimately not provide less CKD grade ≥3 at 36 months compared to normal-dose extended-release TAC. (Copyright © 2023 American Association for the Study of Liver Diseases.)
Databáze:	MEDLINE
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