Everolimus in de novo kidney transplant recipients participating in the Eurotransplant senior program: Results of a prospective randomized multicenter study (SENATOR)
Autoři:
Susanne Brakemeier aff001; Wolfgang Arns aff002; Frank Lehner aff003; Oliver Witzke aff004; Oliver Vonend aff006; Claudia Sommerer aff007; Anja Mühlfeld aff008; Thomas Rath aff009; Robert Schuhmann aff002; Bianca Zukunft aff001; Irena Kroeger aff010; Martina Porstner aff010; Klemens Budde aff001
Působiště autorů:
Department of Nephrology and Medical Intensive Care, Charité Campus Mitte, Berlin, Germany
aff001; Department of Nephrology and Transplantation, Cologne Merheim Medical Center, Cologne, Germany
aff002; Department of General, Visceral and Transplantation Surgery, Hannover Medical School, Hannover, Germany
aff003; Department of Infectious Diseases, University Duisburg-Essen, Essen, Germany
aff004; Department of Nephrology, University Duisburg-Essen, Essen, Germany
aff005; Department of Nephrology, University Dusseldorf, Medical Faculty, Dusseldorf, Germany
aff006; Department of Nephrology, University of Heidelberg, Heidelberg, Germany
aff007; Division of Nephrology and Immunology, University Hospital RWTH Aachen, Aachen, Germany
aff008; Department of Medicine III, Westpfalz- Kaiserslautern, Germany
aff009; Medical Department, Novartis Pharma GmbH, Nürnberg, Germany
aff010
Vyšlo v časopise:
PLoS ONE 14(9)
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pone.0222730
Souhrn
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.
Klíčová slova:
Medicine and health sciences – Surgical and invasive medical procedures – Transplantation – Organ transplantation – Renal transplantation – Urinary system procedures – Pharmacology – Drugs – Immunosuppressives – Geriatrics – Endocrinology – Endocrine disorders – Metabolic disorders – Research and analysis methods – Research design – Clinical research design – Adverse events – People and places – Population groupings – Age groups – Elderly – Biology and life sciences – Biochemistry – Biomarkers – Creatinine – Anatomy – Renal system
Zdroje
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Článek vyšel v časopise
PLOS One
2019 Číslo 9
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