학술논문
Long-term follow-up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT randomized liver transplantation study.
Document Type
Article
Author
Sterneck, Martina; Kaiser, Gernot M.; Heyne, Nils; Richter, Nicolas; Rauchfuss, Falk; Pascher, Andreas; Schemmer, Peter; Fischer, Lutz; Klein, Christian G.; Nadalin, Silvio; Lehner, Frank; Settmacher, Utz; Gotthardt, Daniel; Loss, Martin; Ladenburger, Stephan; Wimmer, Peter; Dworak, Markus; Schlitt, Hans J.
Source
Subject
*KIDNEY diseases
*EVEROLIMUS
*ANTINEOPLASTIC agents
*TRANSPLANTATION of organs, tissues, etc.
*LIVER transplantation
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Language
ISSN
0902-0063
Abstract
Background The 12-month (M) PROTECT study showed that de novo liver transplant recipients ( LTxR) who switched from a calcineurin inhibitor ( CNI)-based immunosuppression to a CNI-free everolimus ( EVR)-based regimen showed numerically better renal function. Here, we present the five-yr follow-up data. Methods PROTECT was a randomized controlled study in which LTxR received basiliximab and CNI-based immunosuppression ± corticosteroids. Patients were randomized 1:1 to receive EVR or continue CNI. Patients completing the core study could enter the extension study on their randomized treatment. Results A total of 81 patients entered the extension study (41, EVR; 40, CNI). At M59 post-randomization, the adjusted mean eGFR was significantly higher in the EVR group, with a benefit of 12.4 mL/min using Cockcroft-Gault (95% CI: 1.2; 23.6; p = 0.0301). Also, there was a significant benefit for adjusted and unadjusted eGFR using the four-variable Modification of Diet in Renal Disease ( MDRD4) or Nankivell formula. During the extension period, treatment failure rates were similar. SAEs occurred in 26 (63.4%) and 28 (70.0%) of the patients in EVR and CNI groups, respectively. Conclusion Compared with the CNI-based treatment, EVR-based CNI-free immunosuppression resulted in significantly better renal function and comparable patient and graft outcomes after five-yr follow-up. [ABSTRACT FROM AUTHOR]