Delayed introduction of reduced-dose tacrolimus, and renal function in liver transplantation: the 'ReSpECT' study

[en] We report a multicenter, prospective, randomized, open-label trial investigating the effect of lower levels and delayed introduction of tacrolimus on renal function in liver transplant recipients. Adult patients with good renal function undergoing primary liver transplant were randomized to either: group A (standard-dose tacrolimus [target trough levels >10 ng/mL] and corticosteroids; n = 183); group B (mycophenolate mofetil [MMF] 2g/day, reduced-dose tacrolimus [target trough levels </=8 ng/mL], and corticosteroids; n = 170); group C (daclizumab induction, MMF, reduced-dose tacrolimus delayed until the fifth day posttransplant and corticosteroids, n = 172). The primary endpoint was change from baseline in estimated glomerular filtration rate (eGFR) at 52 weeks. The eGFR decreased by 23.61, 21.22 and 13.63 mL/min in groups A, B and C, respectively (A vs C, p = 0.012; A vs B, p = 0.199). Renal dialysis was required less frequently in group C versus group A (4.2% vs. 9.9%; p = 0.037). Biopsy-proven acute rejection rates were 27.6%, 29.2% and 19.0%, respectively. Patient and graft survival was similar. In conclusion, daclizumab induction, MMF, corticosteroids and delayed reduced-dose tacrolimus was associated with less nephrotoxicity than therapy with standard-dose tacrolimus and corticosteroids without compromising efficacy or tolerability.

Disciplines :

Surgery
Gastroenterology & hepatology

Author, co-author :

Neuberger, J. M.

Mamelok, R. D.

Neuhaus, P.

Pirenne, J.

Samuel, D.

Isoniemi, H.

Rostaing, L.

Rimola, A.

Marshall, S.

Mayer, A. D.

More authors (27 more)

Language :

English

Title :

Delayed introduction of reduced-dose tacrolimus, and renal function in liver transplantation: the 'ReSpECT' study

Publication date :

February 2009

Journal title :

American Journal of Transplantation

ISSN :

1600-6135

eISSN :

1600-6143

Publisher :

Blackwell Publishing

Volume :

Issue :

Pages :

327-336

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 02 February 2009

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