CompletedPhase 2

Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

United States298 participantsStarted 2009-12

Plain-language summary

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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Inclusion criteria: * Recipients of a first or second kidney transplant from a deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor. * Recipients of a kidney with a cold ischemia time \< 30 hours. * Recipients of a kidney from a donor 10 - 65 years old. Exclusion criteria: * Multi-organ transplant recipients. * Recipients of an organ from an non-heart beating donor. * Patients receiving a second kidney allograft if the first allograft was * Functional for less than three years * Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) at screening and cannot discontinue this treatment. Other protocol-defined inclusion/exclusion criteria may apply

What they're measuring

Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).

Timeframe: Month 6

Trial details

NCT IDNCT01064791

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08

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