Early conversion of pediatric kidney transplant patients to everolimus with reduced tacrolimus and steroid elimination: Results of a randomized trial |
| |
Authors: | Burkhard T nshoff,Robert Ettenger,Luca Dello Strologo,Stephen D. Marks,Lars Pape,Helio Tedesco‐Silva,Anna Bjerre,Martin Christian,Matthias Meier,El‐Djouher Martzloff,Barbara Rauer,Jennifer Ng,Patricia Lopez |
| |
Affiliation: | Burkhard Tönshoff,Robert Ettenger,Luca Dello Strologo,Stephen D. Marks,Lars Pape,Helio Tedesco‐Silva,Anna Bjerre,Martin Christian,Matthias Meier,El‐Djouher Martzloff,Barbara Rauer,Jennifer Ng,Patricia Lopez |
| |
Abstract: | 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 m2 with EVR/rTAC and 72.5 mL/min/1.73 m2 for sTAC/MMF (difference 3.8 mL/min/1.73m2; 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. |
| |
Keywords: | clinical research/practice immunosuppressant— calcineurin inhibitor: tacrolimus immunosuppressant— mechanistic target of rapamycin: everolimus immunosuppressive regimens— minimization/withdrawal kidney transplantation/nephrology pediatrics |
|
|