| Title: |
Early Conversion From Calcineurin Inhibitor- to Everolimus-Based Therapy Following Kidney Transplantation: Results of the Randomized ELEVATE Trial |
| Authors: |
de Fijter, J.W.; Holdaas, H.; Oyen, O.; Sanders, J-S.; Sundar, S.; Bemelman, F.J.; Sommerer, C.; Pascual, J.; Avihingsanon, Y.; Pongskul, C.; Oppenheimer, F.; Toselli, L.; Russ, G.; Wang, Z.; Lopez, P.; Kochuparampil, J.; Cruzado, J.M.; van der Giet, M.; ELEVATE Study Group |
| Contributors: |
Kuypers, Dirk |
| Source: |
ISSN:1600-6135 ; ISSN:1600-6143 ; American Journal Of Transplantation, vol. 17 (7), (1853-1867. |
| Publisher Information: |
Wiley |
| Publication Year: |
2017 |
| Subject Terms: |
Science & Technology; Life Sciences & Biomedicine; Surgery; Transplantation; DONOR-SPECIFIC ANTIBODIES; LEFT-VENTRICULAR MASS; RENAL-TRANSPLANTATION; CARDIAC-HYPERTROPHY; PRESSURE-OVERLOAD; MAMMALIAN TARGET; HLA ANTIBODIES; RECIPIENTS; CYCLOSPORINE; SIROLIMUS; RENAL-FUNCTION; EVOLUTION; calcineurin inhibitor (CNI); cardiovascular disease; clinical research/practice; clinical trial; immunosuppressant; immunosuppression/immune modulation; kidney (allograft) function/dysfunction; kidney transplantation/nephrology; mechanistic target of rapamycin: everolimus; Everolimus; Female; Follow-Up Studies; Glomerular Filtration Rate; Graft Rejection |
| Description: |
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. ; sponsorship: The study was funded by Novartis Pharma AG. Funding for a freelance medical writer was also provided by Novartis Pharma AG. (Novartis Pharma AG) ; status: Published |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
https://lirias.kuleuven.be/handle/123456789/629631; https://doi.org/10.1111/ajt.14186; https://pubmed.ncbi.nlm.nih.gov/28027625 |
| DOI: |
10.1111/ajt.14186 |
| Availability: |
https://lirias.kuleuven.be/handle/123456789/629631; https://lirias.kuleuven.be/retrieve/39f7a32a-ba5d-45ec-a6f4-be8cd5db717f; https://doi.org/10.1111/ajt.14186; https://pubmed.ncbi.nlm.nih.gov/28027625 |
| Rights: |
info:eu-repo/semantics/openAccess ; public |
| Accession Number: |
edsbas.3A84A761 |
| Database: |
BASE |