Martina Sterneck1, Gernot M Kaiser2,3, Nils Heyne4, Nicolas Richter5, Falk Rauchfuss6, Andreas Pascher7, Peter Schemmer8, Lutz Fischer1, Christian G Klein2, Silvio Nadalin4, Frank Lehner5, Utz Settmacher6, Daniel Gotthardt8, Martin Loss9, Stephan Ladenburger10, Peter Wimmer10, Markus Dworak10, Hans J Schlitt9. 1. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 2. Department of General, Visceral and Transplantation Surgery, Essen University Hospital, Essen, Germany. 3. Department of General and Visceral Surgery, St. Bernhard-Hospital Kamp-Lintfort, Kamp-Lintfort, Germany. 4. Department of General, Visceral and Transplant Surgery, University Hospital Tuebingen, Tuebingen, Germany. 5. Clinic for General, Abdominal and Transplant Surgery, Hannover Medical School (MHH), Hannover, Germany. 6. Department of General, Abdominal and Vascular Surgery, Jena University Hospital, Jena, Germany. 7. Clinic for General, Abdominal and Transplant Surgery, Charité University Medical Center Berlin, Berlin, Germany. 8. Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Heidelberg, Germany. 9. Department of Surgery, University Hospital Regensburg, Regensburg, Germany. 10. Novartis Pharma GmbH, Nürnberg, Germany.
Abstract
BACKGROUND: The 12-month (M) PROTECT study showed that de novo liver transplant recipients (LTxR) who switched from acalcineurin 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.
RCT Entities:
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.
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