A Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients.

Trial Profile

A Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients.

Discontinued
Phase of Trial: Phase II

Latest Information Update: 09 Aug 2017

At a glance

  • Drugs Sotrastaurin (Primary) ; Mycophenolic acid; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Therapeutic Use
  • Sponsors Novartis
  • Most Recent Events

    • 23 Jan 2013 Status changed from active, no longer recruiting to discontinued, based on information in Novartis' Form 20-F (http://www.sec.gov/Archives/edgar/data/1114448/000104746913000377/a2212460z20-f.htm).
    • 04 May 2011 Results presented at the American Transplant Congress -- 11th Joint Congress of the American Society of Transplant Surgeons and the American Society of Transplantation.
    • 14 Dec 2010 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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