A Six-Month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation

Trial Profile

A Six-Month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation

Completed
Phase of Trial: Phase IV

Latest Information Update: 08 Nov 2012

At a glance

  • Drugs Ciclosporin (Primary) ; Mycophenolate mofetil; Mycophenolate sodium; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Adverse reactions; Biomarker; Therapeutic Use
  • Acronyms DIRECT; DIRECT
  • Sponsors Novartis
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 28 Jan 2011 Actual end date (Mar 2006) added as reported by ClinicalTrials.gov.
    • 30 Aug 2009 Results of multivariate analysis presented at the 14th Congress of the European Society for Organ Transplantation.
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