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Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Sterneck, M; Kaiser, GM; Heyne, N; Richter, N; Rauchfuss, F; Pascher, A; Schemmer, P; Fischer, L; Klein, CG; Nadalin, S; Lehner, F; Settmacher, U; Gotthardt, D; Loss, M; Ladenburger, S; Wimmer, P; Dworak, M; Schlitt, HJ.
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.
Clin Transplant. 2016; 30(6):741-748
Doi: 10.1111/ctr.12744
Web of Science
PubMed
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- Co-authors Med Uni Graz
- Schemmer Peter
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- Abstract:
- 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. 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. 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. 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. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Calcineurin Inhibitors - administration & dosage
- Everolimus - administration & dosage
- Female -
- Follow-Up Studies -
- Graft Rejection - drug therapy
- Graft Rejection - etiology
- Graft Survival - drug effects
- Humans -
- Immunosuppressive Agents - administration & dosage
- Kidney Function Tests -
- Liver Diseases - surgery
- Liver Transplantation - adverse effects
- Male -
- Prospective Studies -
- Treatment Outcome -
- Withholding Treatment -
- Find related publications in this database (Keywords)
- calcineurin inhibitors
- everolimus
- long-term follow-up
- renal function