Everolimus With Reduced Tacrolimus Improves Renal Function in De Novo Liver Transplant Recipients: A Randomized Controlled Trial

In a prospective, multicenter, open‐label study, de novo liver transplant patients were randomized at day 30±5 to (i) everolimus initiation with tacrolimus elimination (TAC Elimination) (ii) everolimus initiation with reduced‐exposure tacrolimus (EVR+Reduced TAC) or (iii) standard‐exposure tacrolimu...

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Veröffentlicht in:American journal of transplantation 2012-11, Vol.12 (11), p.3008-3020
Hauptverfasser: De Simone, P., Nevens, F., De Carlis, L., Metselaar, H. J., Beckebaum, S., Saliba, F., Jonas, S., Sudan, D., Fung, J., Fischer, L., Duvoux, C., Chavin, K. D., Koneru, B., Huang, M. A., Chapman, W. C., Foltys, D., Witte, S., Jiang, H., Hexham, J. M., Junge, G.
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Sprache:eng
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Zusammenfassung:In a prospective, multicenter, open‐label study, de novo liver transplant patients were randomized at day 30±5 to (i) everolimus initiation with tacrolimus elimination (TAC Elimination) (ii) everolimus initiation with reduced‐exposure tacrolimus (EVR+Reduced TAC) or (iii) standard‐exposure tacrolimus (TAC Control). Randomization to TAC Elimination was terminated prematurely due to a higher rate of treated biopsy‐proven acute rejection (tBPAR). EVR+Reduced TAC was noninferior to TAC Control for the primary efficacy endpoint (tBPAR, graft loss or death at 12 months posttransplantation): 6.7% versus 9.7% (−3.0%; 95% CI −8.7, 2.6%; p
ISSN:1600-6135
1600-6143
DOI:10.1111/j.1600-6143.2012.04212.x