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OpenTrials
Completed

NCT Number: NCT01128335

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

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

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

Drug

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

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

Drug

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 21, 2010
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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