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Early conversion of pediatric kidney transplant patients to everolimus with reduced tacrolimus and steroid elimination: Results of a randomized trial
Author(s) -
Tönshoff Burkhard,
Ettenger Robert,
Dello Strologo Luca,
Marks Stephen D.,
Pape Lars,
TedescoSilva Helio,
Bjerre Anna,
Christian Martin,
Meier Matthias,
Martzloff ElDjouher,
Rauer Barbara,
Ng Jennifer,
Lopez Patricia
Publication year - 2019
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.15081
Subject(s) - medicine , tacrolimus , everolimus , urology , renal function , mycophenolate , transplantation , kidney transplantation , regimen , randomized controlled trial , mycophenolic acid , gastroenterology , surgery
In a 12‐month, multicenter, open‐label study, 106 children were randomized at 4 to 6 weeks after kidney transplantation to switch to everolimus with reduced TAC (EVR/rTAC) and steroid elimination from month 5 posttransplant or to continue standard tacrolimus with mycophenolate mofetil (sTAC/MMF) and steroids. The cumulative incidence of a co‐primary efficacy end point (biopsy‐proven acute rejection [BPAR], graft loss, or death from randomization to month 12) was 10.3% with EVR/rTAC and 5.8% with sTAC/MMF (difference 4.4%; P = .417). BPAR occurred in 9.6% and 5.6% of patients, respectively. Patient and renal allograft survival were 100%. The co‐primary end point of mean estimated glomerular filtration rate at month 12 was 76.2 mL/min/1.73 m 2 with EVR/rTAC and 72.5 mL/min/1.73 m 2 for sTAC/MMF (difference 3.8 mL/min/1.73m 2 ; P = .49). One EVR/rTAC patient developed posttransplant lymphoproliferative disease. Longitudinal growth and sexual maturation were equivalent between groups. The randomized drug regimen was discontinued in 34.6% and 13% of patients in the EVR/rTAC and sTAC/MMF groups, respectively ( P = .024), and discontinued due to adverse events/infections in 25.0% and 11.1% of patients ( P = .062). In conclusion, early conversion of pediatric kidney transplant patients from TAC, MMF, and steroids to EVR/rTAC and steroid withdrawal maintains immunosuppressive efficacy and preserves renal function.