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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:
ClinicalTrials.gov Identifier:
NCT01128335
First Posted: May 21, 2010
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: Quadruple (Participant, Care Provider, 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 ( Novartis Pharmaceuticals ):

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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01128335     History of Changes
Other Study ID Numbers: CAEB071B2201
2007-001776-36
First Submitted: May 20, 2010
First Posted: May 21, 2010
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Liver transplantation
HCV-negative recipient
deceased donor
sotrastaurin
oran transplantation
tacrolimus

Additional relevant MeSH terms:
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents