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

Midas B. Mulder*, Bart Van Hoek, Aad P. Van Den Berg, Wojciech G. Polak, Ian P.J. Alwayn, Koert P. De Jong, Brenda C.M. De Winter, Elke Verhey-Hart, Nicole S. Erler, Caroline M. Den Hoed, Herold J. Metselaar

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)184-195
Number of pages12
JournalLiver Transplantation
Volume29
Issue number2
DOIs
Publication statusPublished - Feb 2023

Bibliographical note

Funding Information:
Funding information This research was funded by the Foundation for Liver and Gastrointestinal Research (SLO) and Astellas Pharma Inc.

Publisher Copyright:
© 2023 John Wiley and Sons Ltd. All rights reserved.

Fingerprint

Dive into the research topics of 'Three-year results of renal function in liver transplant recipients on low-dose sirolimus and tacrolimus: a multicenter, randomized, controlled trial'. Together they form a unique fingerprint.

Cite this