Trial record 1 of 2 for:    sotrastaurin liver transplant
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Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01128335
First received: May 20, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
Drug: MMF(1000mg bid) + tacrolimus + standard of care medications
Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: April 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
MMF(1000mg bid) + tacrolimus + standard of care medications
Drug: MMF(1000mg bid) + tacrolimus + standard of care medications
MMF(1000mg bid) + tacrolimus + standard of care medications
Experimental: Arm 2
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Experimental: Arm 3
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Experimental: Arm 4
sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128335

  Show 39 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01128335     History of Changes
Other Study ID Numbers: CAEB071B2201, 2007-001776-36
Study First Received: May 20, 2010
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Ministry of Health & Long Term Care, Ontario
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Italy: The Italian Medicines Agency
Spain: Ministry of Health
Switzerland: Swissmedic

Keywords provided by Novartis:
Liver transplantation
HCV-negative recipient
deceased donor

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014