AST/AJT Journal Club: ""Three‐year outcomes from the CRADLE study..."
October 1, 2020 from 03:00pm to 04:00pm EDT
Recorded live on Thursday, October 1, 2020 • Hosted jointly by the TxPharm & Pediatric Communities of Practice
"Three‐year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal."
(Am J Transplant . 2020 May 14. doi: 10.1111/ajt.16005.)
In this article:
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 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)
Robert Ettenger, MD • David Geffen School of Medicine at UCLA, Los Angeles, CA
Nicole Hayde, MD, MS • Albert Einstein College of Medicine, New York, NY
Justin Chen, PharmD • New York-Presbyterian Hospital, New York, NY