1. Three-year results of renal function in liver transplant recipients on low-dose sirolimus and tacrolimus: a multicenter, randomized, controlled trial.
- Author
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Mulder MB, van Hoek B, van den Berg AP, Polak WG, Alwayn IPJ, de Jong KP, de Winter BCM, Verhey-Hart E, Erler NS, den Hoed CM, and Metselaar HJ
- Subjects
- Humans, Tacrolimus therapeutic use, Sirolimus adverse effects, Immunosuppressive Agents therapeutic use, Kidney physiology, Graft Rejection epidemiology, Graft Rejection prevention & control, Graft Rejection drug therapy, Graft Survival, Liver Transplantation adverse effects, Kidney Transplantation adverse effects, Renal Insufficiency, Chronic diagnosis, Renal Insufficiency, Chronic chemically induced
- 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., (Copyright © 2023 American Association for the Study of Liver Diseases.)
- Published
- 2023
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