A 12-month, multicenter, open label, randomized, controlled study to evaluate the efficacy, tolerability and safety of early introduction of everolimus, reduced CNI, and early steroid elimination compared to standard CNI, mycophenolate mofetil and steroid regimen in paediatric renal transplant recipients with a 24-month additional safety follow-up.

Trial Profile

A 12-month, multicenter, open label, randomized, controlled study to evaluate the efficacy, tolerability and safety of early introduction of everolimus, reduced CNI, and early steroid elimination compared to standard CNI, mycophenolate mofetil and steroid regimen in paediatric renal transplant recipients with a 24-month additional safety follow-up.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 May 2017

At a glance

  • Drugs Everolimus (Primary) ; Corticosteroids; Mycophenolate mofetil; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Registrational; Therapeutic Use
  • Acronyms CRADLE
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals; Novartis Pharmaceuticals Corporation
  • Most Recent Events

    • 03 May 2017 Results (N=106) of 12 month study assessing efficacy and safety presented at the 2017 American Transplant Congress.
    • 28 Feb 2017 Planned End Date changed from 1 Dec 2016 to 5 Oct 2018.
    • 28 Feb 2017 Planned primary completion date changed from 1 Dec 2016 to 5 Oct 2018.
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