Premium
Long‐term outcomes after cyclosporine or mycophenolate withdrawal in kidney transplantation – results from an aborted trial
Author(s) -
Åsberg Anders,
Apeland Terje,
Reisæter Anna V.,
Foss Aksel,
Leivestad Torbjørn,
Heldal Kristian,
Thorud Lars O.,
Eriksen Bjørn O.,
Hartmann Anders
Publication year - 2013
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.12076
Subject(s) - medicine , mycophenolic acid , immunosuppression , transplantation , kidney transplantation , prednisolone , mycophenolate , randomized controlled trial , surgery , urology , gastroenterology
Long‐term triple immunosuppressive therapy with cyclosporine ( C s A ), mycophenolate mofetil ( MMF ) and prednisolone may be excessively powerful for many transplant recipients. We compared withdrawal of either MMF or C s A in stable kidney transplants on triple immunosuppression. The study was a prospective, randomized, controlled 12‐months trial in stable kidney transplants. The patients who withdrew C s A were given MMF 2 g/d, and C s A troughs were between 75 and 125 ng/mL in MMF withdrawal. Planned inclusion was 298 patients. The study was prematurely aborted after inclusion of 39 patients. Acute rejection rates were 6/20 (30%) in the MMF group compared with 0/19 (0%) in the C s A group (p = 0.02). Time to acute rejections was 4.0–28.7 months after withdrawal. Trough concentrations of mycophenolic acid ( MPA ) and C s A showed therapeutic levels. The subjects have been observed for eight yr, and of the 28 patients remaining on randomized therapy, the MMF patients preserved graft function better than C s A patients. Death‐censored graft survival was 75% and 95% (p = 0.18) and patient survival was 70% and 68% (p = 0.99) in the MMF and C s A groups, respectively, at the end of long‐term follow‐up. C s A withdrawal was associated with a high rate of acute rejections. Initially, the treatment of acute rejections was successful. However, five of six lost their grafts in the long term.