Open AccessRenal function three years after early conversion from a calcineurin inhibitor to everolimus: results from a randomized trial in kidney transplantation
Author(s) -
Mjörnstedt Lars,
Schwartz Sørensen Søren,
zur Mühlen Bengt,
Jespersen Bente,
Hansen Jesper M.,
Bistrup Claus,
Andersson Helene,
Gustafsson Bengt,
Solbu Dag,
Holdaas Hallvard
Publication year - 2015
Publication title -
transplant international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.998
H-Index - 82
eISSN - 1432-2277
pISSN - 0934-0874
DOI - 10.1111/tri.12437
Subject(s) - everolimus , medicine , urology , randomization , renal function , transplantation , discontinuation , calcineurin , kidney transplantation , randomized controlled trial , adverse effect , sirolimus , nephrology , kidney disease , gastroenterology , surgery
Summary In a 36‐month, open‐label, multicenter trial, 202 kidney transplant recipients were randomized at week 7 post‐transplant to convert to everolimus or remain on cyclosporine: 182 were analyzed to month 36 (92 everolimus, 90 controls). Mean (SD) change in measured GFR ( mGFR ) from randomization to month 36 was 1.3 (14.0) ml/min with everolimus versus −1.7 (15.4) ml/min in controls ( P = 0.210). In patients who remained on treatment, mean mGFR improved from randomization to month 36 by 7.9 (11.5) ml/min with everolimus ( n = 37) but decreased by 1.4 (14.7) ml/min in controls ( n = 62) ( P = 0.001). During months 12–36, death‐censored graft survival was 100%, patient survival was 98.9% and 96.7% in the everolimus and control groups, respectively, and 13.0% and 11.1% of everolimus and control patients, respectively, experienced mild biopsy‐proven acute rejection (BPAR). Protocol biopsies in a limited number of on‐treatment patients showed similar interstitial fibrosis progression. Donor‐specific antibodies were present at month 36 in 6.3% (2/32) and 18.0% (9/50) of on‐treatment everolimus and control patients with available data ( P = 0.281). During months 12‐36, adverse events were comparable, but discontinuation was more frequent with everolimus (33.7% vs. 10.0%). Conversion from cyclosporine to everolimus at 7 weeks post‐transplant was associated with a significant benefit in renal function at 3 years when everolimus was continued.