Journal Article

Everolimus in de novo kidney transplant recipients participating in the Eurotransplant senior program: Results of a prospective randomized multicenter study (SENATOR)

Brakemeier, Susanne, Lehner, Frank, Witzke, Oliver, Vonend, Oliver, Kroeger, Irena, Zukunft, Bianca, Porstner, Martina, Arns, Wolfgang, Budde, Klemens, Sommerer, Claudia, Rath, Thomas, Mühlfeld, Anja, Schuhmann, Robert

2019

Overview

Early conversion to everolimus was assessed in kidney transplant recipients participating in the Eurotransplant Senior Program (ESP), a population in whom data are lacking. The SENATOR multicenter study enrolled 207 kidney transplant recipients undergoing steroid withdrawal at week 2 post-transplant (ClinicalTrials.gov [NCT00956293]). At week 7, patients were randomized (1:2 ratio) to continue the previous calcineurin inhibitor (CNI)-based regimen with mycophenolic acid (MPA) and cyclosporine or switch to a CNI-free regimen with MPA, everolimus (5-10 ng/mL) and basiliximab at weeks 7 and 12, then followed for 18 weeks to month 6 post-transplant. The primary endpoint was estimated GFR (eGFR). At week 7, 77/207 (37.2%) patients were randomized (53 everolimus, 24 control). At month 6, eGFR was comparable: 36.5±10.8ml/min with everolimus versus 42.0±13.0ml/min in the control group (p = 0.784). Discontinuation due to adverse events occurred in 27.8% of everolimus-treated patients and 0.0% of control patients (p = 0005). Efficacy profiles showed no difference. In conclusion, eGFR, safety and efficacy outcomes at month 6 post-transplant showed no difference between groups. The everolimus group experienced a higher rate of discontinuation due to adverse events. However, the high rate of non-randomization is highly relevant, indicating this to be a somewhat unstable patient population regardless of treatment.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Aged / Analysis / Angiogenesis inhibitors / Basiliximab / Basiliximab - administration & dosage / Biology and Life Sciences / Calcineurin / Calcineurin inhibitors / Calcineurin Inhibitors - administration & dosage / Clinical trials / Cyclosporine - administration & dosage / Cyclosporins / Epidermal growth factor receptors / Everolimus / Everolimus - administration & dosage / Everolimus - adverse effects / FDA approval / Female / Glomerular Filtration Rate - drug effects / Glomerular Filtration Rate - physiology / Graft Rejection - diagnosis / Graft Rejection - prevention & control / Health aspects / Humans / Immunosuppressive agents / Immunosuppressive Agents - administration & dosage / Immunosuppressive Agents - adverse effects / Inhibitor drugs / Intensive care / Kidney transplantation / Kidney Transplantation - methods / Kidney transplants / Kidneys / Male / Medicine and Health Sciences / Monoclonal antibodies / Mycophenolic acid / Mycophenolic Acid - administration & dosage / Nephrology / Organ transplant recipients / Outcome Assessment, Health Care - methods / Outcome Assessment, Health Care - statistics & numerical data / Patients / People and Places / Prospective Studies / Randomization / Research and Analysis Methods / Social services / Steroids / Studies / Systematic review / Time Factors / Transplants & implants