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

A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01128335

Enrollment

200

Registered

2010-05-21

Start date

2010-04-30

Completion date

2012-07-31

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Keywords

Liver transplantation, HCV-negative recipient, deceased donor, sotrastaurin, oran transplantation, tacrolimus

Brief 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 liver transplantation.

Interventions

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

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

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

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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.	Month 6

Secondary

Measure	Time frame
Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockcroft-Gault formula; serum creatinine).	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.	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	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).	Months 3, 6, 12, 24

Countries

Argentina, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Italy, Spain, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026