Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients

Novartis Pharmaceuticals200 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 liver transplantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

200

Conditions

Liver Transplantation

Interventions

MMF(1000mg bid) + tacrolimus + standard of care medicationsDRUG

MMF(1000mg bid) + tacrolimus + standard of care medications

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

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

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Recipients of any race, 18 years or older * Recipients of primary de novo orthotopic liver transplant from a deceased donor * Recipients of a kidney with a cold ischemia time \< 30 hours * HCV-negative recipients Exclusion criteria: * Prior organ/cellular transplant or multiple organ transplant * MELD-score \> 35 * HCC \> Milan criteria * Donor age \< 12 years * Cold ischemia \> 15 hours * Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) or drugs with QT-prolonging properties Other protocol-defined inclusion/exclusion criteria may apply

Locations (39)

Outcomes

Primary Outcomes

Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.

Time frame: Month 6

Secondary Outcomes

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

Time frame: Months 3, 6, 12, and 24

Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.

Time frame: Months 12, 24

Occurrence of rejection requiring T-cell depleting antibody, occurrence of treated biopsy-proven acute rejections of Banff grade ≥ 1 that is steroid-resistant

Time frame: Months 6, 12, 24

Safety and tolerability ((serious) adverse events (specifically: gastrointestinal AEs and cardiac AEs, serious infections), laboratory abnormalities, vital signs, electrocardiograms, physical examination).

Time frame: Months 3, 6, 12, 24

Data from ClinicalTrials.gov

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Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

San Francisco, California, United States

Novartis Investigative Site

Detroit, Michigan, United States

Novartis Investigative Site

Minneapolis, Minnesota, United States

Novartis Investigative Site

Rochester, Minnesota, United States

Novartis Investigative Site

Cincinnati, Ohio, United States

Novartis Investigative Site

Dallas, Texas, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

...and 29 more locations