학술논문
Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal.
Document Type
Academic Journal
Author
Tönshoff B; Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.; Tedesco-Silva H; Nephrology Division, Hospital do Rim, UNIFESP, São Paulo, Brazil.; Ettenger R; Division of Pediatric Nephrology, UCLA Mattel Children's Hospital, Los Angeles, California, USA.; Christian M; Department of Pediatric Nephrology, Nottingham Children's Hospital, Nottingham, UK.; Bjerre A; Division of Pediatric and Adolescent Medicine, Department of Pediatrics, Oslo University Hospital, Oslo, Norway.; Dello Strologo L; Nephrology Unit, Department of Pediatrics, Institute for Scientific Research, Bambino Gesù Children's Hospital, Rome, Italy.; Marks SD; Department of Pediatric Nephrology, Great Ormond Street Hospital for Children, NHS Foundation Trust and University College London Great Ormond Street Institute of Child Health, NIHR Great Ormond Street Hospital Biomedical Research Centre, London, UK.; Pape L; Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany.; Veldandi U; Novartis Healthcare Pvt. Ltd., Hyderabad, India.; Lopez P; Novartis Pharma AG, Basel, Switzerland.; Cousin M; Novartis Pharma AG, Basel, Switzerland.; Pandey P; Novartis Healthcare Pvt. Ltd., Hyderabad, India.; Meier M; Novartis Pharma AG, Basel, Switzerland.
Source
Publisher: Elsevier Country of Publication: United States NLM ID: 100968638 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1600-6143 (Electronic) Linking ISSN: 16006135 NLM ISO Abbreviation: Am J Transplant Subsets: MEDLINE
Subject
Language
English
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 m 2 ). 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.)
(© 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.)