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Evaluation of renal function in liver transplant recipients receiving daclizumab (Zenapax), mycophenolate mofetil, and a delayed, low‐dose tacrolimus regimen vs. a standard‐dose tacrolimus and mycophenolate mofetil regimen: A multicenter randomized clinical trial
Author(s) -
Yoshida Eric M.,
Marotta Paul J.,
Greig Paul D.,
Kneteman Norman M.,
Marleau Denis,
Cantarovich Marcelo,
Peltekian Kevork M.,
Lilly Leslie B.,
Scudamore Charles H.,
Bain Vincent G.,
Wall William J.,
Roy Andre,
Balshaw Robert F.,
Barkun Jeffrey S.T.
Publication year - 2005
Publication title -
liver transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.814
H-Index - 150
eISSN - 1527-6473
pISSN - 1527-6465
DOI - 10.1002/lt.20490
Subject(s) - medicine , daclizumab , tacrolimus , urology , renal function , regimen , calcineurin , transplantation , liver transplantation , gastroenterology
Posttransplant chronic renal failure, secondary to calcineurin inhibitor agents, is emerging as a major problem in liver transplantation. We report a randomized clinical trial comparing daclizumab, delayed low‐dose tacrolimus (target trough level 4‐8 ng/mL, starting day 4‐6), Investigational Arm (n = 72), to standard tacrolimus induction/maintenance dosing, Standard Arm (n = 76), with mycophenolate mofetil and tapering corticosteroids in both study arms. The end‐points were renal function indicated by the Modification of Diet in Renal Disease (MDRD). There was no significant difference in patient survival (86.6% Investigational Arm vs. 92.9% Standard Arm; P = 0.21) or acute rejection (23.2% vs. 27.7%, respectively; P = 0.68). Statistically significant differences in median glomerular filtration rate (GFR) were found in favor of the Investigational Arm. With the CG equation, the GFR at the end of the first week was 110.7 vs. 89.6 mL/min ( P = 0.019) without significant differences thereafter. With the MDRD, statistically significant differences extended to the first posttransplant month (86.8 vs. 70.1 mL/min/1.73 m 2 ; P < 0.001) with and was seen at month 6 (75.4 vs. 69.5 mL/min/1.73 m 2 ; P = 0.038). In conclusion, delayed low‐dose tacrolimus, in combination with daclizumab and mycophenolate mofetil, preserves early renal function post–liver transplantation without the cost of increased acute rejection. (Liver Transpl 2005;11:1064–1072.)