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

Novartis Pharmaceuticals298 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

298

Conditions

Renal Transplantation

Interventions

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

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

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

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

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (44)

Outcomes

Primary Outcomes

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).

Time frame: Month 6

Secondary Outcomes

Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine)

Time frame: Months 6, 12, 24, and 36

Time frame: Months 12, 24, and 36

Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).

Time frame: Months 6, 12, 24, and 36

Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).

Time frame: Months 6, 12, 24, and 36

Data from ClinicalTrials.gov

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Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Aurora, Colorado, United States

Novartis Investigative Site

Ann Arbor, Michigan, United States

Novartis Investigative Site

Detroit, Michigan, United States

Novartis Investigative Site

Cincinnati, Ohio, United States

Novartis Investigative Site

Cincinnati, Ohio, United States

Novartis Investigative Site

Madison, Wisconsin, United States

Novartis Investigative Site

Corrientes, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Córdoba, Argentina

...and 34 more locations