TY - JOUR
T1 - Three-year results of renal function in liver transplant recipients on low-dose sirolimus and tacrolimus
T2 - a multicenter, randomized, controlled trial
AU - Mulder, Midas B.
AU - Van Hoek, Bart
AU - Van Den Berg, Aad P.
AU - Polak, Wojciech G.
AU - Alwayn, Ian P.J.
AU - De Jong, Koert P.
AU - De Winter, Brenda C.M.
AU - Verhey-Hart, Elke
AU - Erler, Nicole S.
AU - Den Hoed, Caroline M.
AU - Metselaar, Herold J.
N1 - Publisher Copyright:
© 2023 John Wiley and Sons Ltd. All rights reserved.
PY - 2023/2
Y1 - 2023/2
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85163759102&partnerID=8YFLogxK
U2 - 10.1097/LVT.0000000000000003
DO - 10.1097/LVT.0000000000000003
M3 - Article
AN - SCOPUS:85163759102
SN - 1527-6465
VL - 29
SP - 184
EP - 195
JO - Liver Transplantation
JF - Liver Transplantation
IS - 2
ER -