Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal.
clinical research/practice
glomerular filtration rate (GFR)
graft survival
immunosuppressant-mechanistic target of rapamycin: everolimus
immunosuppressive regimens-minimization/withdrawal
kidney transplantation/nephrology
patient safety
Journal
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
ISSN: 1600-6143
Titre abrégé: Am J Transplant
Pays: United States
ID NLM: 100968638
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
03
10
2019
revised:
27
04
2020
accepted:
30
04
2020
pubmed:
15
5
2020
medline:
22
6
2021
entrez:
15
5
2020
Statut:
ppublish
Résumé
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
Identifiants
pubmed: 32406111
doi: 10.1111/ajt.16005
pii: S1600-6135(22)08323-X
doi:
Substances chimiques
Immunosuppressive Agents
0
Steroids
0
Everolimus
9HW64Q8G6G
Mycophenolic Acid
HU9DX48N0T
Tacrolimus
WM0HAQ4WNM
Banques de données
ClinicalTrials.gov
['NCT01544491']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
123-137Commentaires et corrections
Type : CommentIn
Informations de copyright
© 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.
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