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

CompletadoFase 2ClinicalTrials.gov

ID: NCT01064791Tipo: INTERVENTIONALInicio: 1 de dic de 2009Fin estimado: 1 de ago de 2012

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

sotrastaurin (Dose 1) + tacrolimus + standard of care medications

sotrastaurin (100mg bid) + tacrolimus + standard of care medications

drug

sotrastaurin (Dose 2) + tacrolimus + standard of care medications

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

drug

sotrastaurin (Dose 3) + tacrolimus + standard of care medications

sotrastaurin (300mg bid) + tacrolimus + standard of care medications

drug

mycophenolic acid + tacrolimus + standard of care medications

mycophenolic acid (720mg bid) + tacrolimus + standard of care medications

Ubicaciones

Novartis Investigative Site

Corrientes, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Córdoba, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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