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Early Conversion From Calcineurin Inhibitor- to Everolimus-Based Therapy Following Kidney Transplantation: Results of the Randomized ELEVATE Trial
- Source :
- American journal of transplantation, 17(7), 1853-1867. Wiley-Blackwell, American Journal of Transplantation, 17(7), 1853-1867, American Journal of Transplantation, 17(7), 1853-1867. Wiley
- Publication Year :
- 2017
-
Abstract
- none 24 si In a 24-month, multicenter, open-label, randomized trial, 715 de novo kidney transplant recipients were randomized at 10-14 weeks to convert to everolimus (n = 359) or remain on standard calcineurin inhibitor (CNI) therapy (n = 356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and steroids. The primary endpoint, change in estimated glomerular filtration rate (eGFR) from randomization to month 12, was similar for everolimus versus CNI: mean (standard error) 0.3(1.5) mL/min/1.732 versus -1.5(1.5) mL/min/1.732 (p = 0.116). Biopsy-proven acute rejection (BPAR) at month 12 was more frequent under everolimus versus CNI overall (9.7% vs. 4.8%, p = 0.014) and versus tacrolimus-treated patients (2.6%, p < 0.001) but similar to cyclosporine-treated patients (8.8%, p = 0.755). Reporting on de novo donor-specific antibodies (DSA) was limited but suggested more frequent anti-HLA Class I DSA under everolimus. Change in left ventricular mass index was similar. Discontinuation due to adverse events was more frequent with everolimus (23.6%) versus CNI (8.4%). In conclusion, conversion to everolimus at 10-14 weeks posttransplant was associated with renal function similar to that with standard therapy overall. Rates of BPAR were low in all groups, but lower with tacrolimus than everolimus open de Fijter JW, Holdaas H, Øyen O, Sanders JS, Sundar S, Bemelman FJ, Sommerer C, Pascual J, Avihingsanon Y, Pongskul C, Oppenheimer F, Toselli L, Russ G, Wang Z, Lopez P, Kochuparampil J, Cruzado JM, van der Giet M; ELEVATE Study Group: [...; Guido Garosi; Paolo Rigotti; Giuseppe Tisone; Paola Todeschini; ...] de Fijter JW, Holdaas H, Øyen O, Sanders JS, Sundar S, Bemelman FJ, Sommerer C, Pascual J, Avihingsanon Y, Pongskul C, Oppenheimer F, Toselli L, Russ G, Wang Z, Lopez P, Kochuparampil J, Cruzado JM, van der Giet M; ELEVATE Study Group: [..; Guido Garosi; Paolo Rigotti; Giuseppe Tisone; Paola Todeschini; ..]
- Subjects :
- Graft Rejection
Male
HLA ANTIBODIES
immunosuppressant
kidney transplantation/nephrology
ELEVATE study
SIROLIMUS
immunosuppression/immune modulation
030204 cardiovascular system & hematology
030230 surgery
Pharmacology
Kidney Function Tests
Kidney Failure
0302 clinical medicine
Postoperative Complications
cardiovascular disease
Risk Factors
Clinical endpoint
Immunology and Allergy
DONOR-SPECIFIC ANTIBODIES
Pharmacology (medical)
Chronic
CARDIAC-HYPERTROPHY
Kidney transplantation
calcineurin inhibitor (CNI)
clinical research/practice
clinical trial
kidney (allograft) function/dysfunction
mechanistic target of rapamycin: everolimus
Everolimus
Female
Follow-Up Studies
Glomerular Filtration Rate
Graft Survival
Humans
Immunosuppressive Agents
Kidney Failure, Chronic
Kidney Transplantation
Middle Aged
Prognosis
Tacrolimus
RENAL-TRANSPLANTATION
Kidney transplant, ELEVATE study, Certican
Life Sciences & Biomedicine
medicine.drug
medicine.medical_specialty
Certican
Urology
Renal function
Mycophenolic acid
03 medical and health sciences
LEFT-VENTRICULAR MASS
PRESSURE-OVERLOAD
medicine
Kidney transplant
Transplantation
Science & Technology
business.industry
medicine.disease
Settore MED/18
Calcineurin
RECIPIENTS
MAMMALIAN TARGET
Sirolimus
CYCLOSPORINE
Surgery
business
Subjects
Details
- Language :
- English
- ISSN :
- 16006135
- Database :
- OpenAIRE
- Journal :
- American journal of transplantation, 17(7), 1853-1867. Wiley-Blackwell, American Journal of Transplantation, 17(7), 1853-1867, American Journal of Transplantation, 17(7), 1853-1867. Wiley
- Accession number :
- edsair.doi.dedup.....d4aa2acc479b42f592e5e949b00078a8