Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal: American Journal of Transplantation

B. Tönshoff, H. Tedesco-Silva, R. Ettenger, M. Christian, A. Bjerre, L. Dello Strologo, S.D. Marks, L. Pape, U. Veldandi, P. Lopez, M. Cousin, P. Pandey, M. Meier

Research output: Contribution to journalArticlepeer-review

Abstract

CRADLE was a 36-month multicenter study in pediatric (≥1 to <18 years) kidney transplant recipients randomized at 4 to 6 weeks posttransplant to receive everolimus + reduced-exposure tacrolimus (EVR + rTAC; n = 52) with corticosteroid withdrawal at 6-month posttransplant or continue mycophenolate mofetil + standard-exposure TAC (MMF + sTAC; n = 54) with corticosteroids. The incidence of composite efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, or death) at month 36 was 9.8% vs 9.6% (difference: 0.2%; 80% confidence interval: −7.3 to 7.7) for EVR + rTAC and MMF + sTAC, respectively, which was driven by BPARs. Graft loss was low (2.1% vs 3.8%) with no deaths. Mean estimated glomerular filtration rate at month 36 was comparable between groups (68.1 vs 67.3 mL/min/1.73 m2). Mean changes (z-score) in height (0.72 vs 0.39; P =.158) and weight (0.61 vs 0.82; P =.453) from randomization to month 36 were comparable, whereas growth in prepubertal patients on EVR + rTAC was better (P =.050) vs MMF + sTAC. The overall incidence of adverse events (AEs) and serious AEs was comparable between groups. Rejection was the leading AE for study drug discontinuation in the EVR + rTAC group. In conclusion, though AE-related study drug discontinuation was higher, an EVR + rTAC regimen represents an alternative treatment option that enables withdrawal of steroids as well as reduction of CNIs for pediatric kidney transplant recipients. ClinicalTrials.gov: NCT01544491. © 2020 The Authors. American Journal of Transplantation published by Wiley Periodicals LLC on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons
Original languageEnglish
Pages (from-to)123-137
Number of pages15
JournalAm. J. Transplant.
Volume21
Issue number1
DOIs
Publication statusPublished - 2021

Keywords

  • clinical research/practice
  • glomerular filtration rate (GFR)
  • graft survival
  • immunosuppressant—mechanistic target of rapamycin: everolimus
  • immunosuppressive regimens—minimization/withdrawal
  • kidney transplantation/nephrology
  • patient safety
  • basiliximab
  • corticosteroid
  • creatinine
  • everolimus
  • mycophenolate mofetil
  • tacrolimus
  • acute graft rejection
  • aphthous stomatitis
  • Article
  • body height
  • body weight
  • child
  • clinical outcome
  • controlled study
  • creatinine blood level
  • cytomegalovirus infection
  • death
  • drug dose reduction
  • drug withdrawal
  • end stage renal disease
  • Epstein Barr virus infection
  • estimated glomerular filtration rate
  • female
  • fever
  • graft failure
  • graft recipient
  • graft rejection
  • human
  • immunosuppressive treatment
  • infection
  • kidney transplantation
  • major clinical study
  • male
  • multicenter study
  • neutropenia
  • pediatric surgery
  • phase 3 clinical trial
  • prepuberty
  • priority journal
  • randomized controlled trial
  • rhinopharyngitis
  • school child
  • side effect

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