Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01064791
First received: February 2, 2010
Last updated: June 16, 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 renal transplantation.


Condition Intervention Phase
Renal Transplantation
Drug: sotrastaurin (Dose 1) + tacrolimus + standard of care medications
Drug: sotrastaurin (Dose 2) + tacrolimus + standard of care medications
Drug: sotrastaurin (Dose 3) + tacrolimus + standard of care medications
Drug: mycophenolic acid + 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 Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up). [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine) [ Time Frame: Months 6, 12, 24, and 36 ] [ Designated as safety issue: Yes ]
  • Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up). [ Time Frame: Months 12, 24, and 36 ] [ Designated as safety issue: Yes ]
  • Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category). [ Time Frame: Months 6, 12, 24, and 36 ] [ Designated as safety issue: Yes ]
  • Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination). [ Time Frame: Months 6, 12, 24, and 36 ] [ Designated as safety issue: Yes ]

Enrollment: 298
Study Start Date: December 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
sotrastaurin (100mg bid) + tacrolimus + standard of care medications
Drug: sotrastaurin (Dose 1) + tacrolimus + standard of care medications
sotrastaurin (100mg bid) + tacrolimus + standard of care medications
Experimental: Arm 2
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Drug: sotrastaurin (Dose 2) + tacrolimus + standard of care medications
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Experimental: Arm 3
sotrastaurin (300mg bid) + tacrolimus + standard of care medications
Drug: sotrastaurin (Dose 3) + tacrolimus + standard of care medications
sotrastaurin (300mg bid) + tacrolimus + standard of care medications
Active Comparator: Arm 4
mycophenolic acid (720mg bid) + tacrolimus + standard of care medications
Drug: mycophenolic acid + tacrolimus + standard of care medications
mycophenolic acid (720mg 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 a first or second kidney transplant from a deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
  • Recipients of a kidney with a cold ischemia time < 30 hours.
  • Recipients of a kidney from a donor 10 - 65 years old.

Exclusion criteria:

  • Multi-organ transplant recipients.
  • Recipients of an organ from an non-heart beating donor.
  • Patients receiving a second kidney allograft if the first allograft was
  • Functional for less than three years
  • Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) at screening and cannot discontinue this treatment.

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: NCT01064791

  Show 44 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmceuticals Novartis Pharmceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01064791     History of Changes
Other Study ID Numbers: CAEB071A2214, 2009-015456-14
Study First Received: February 2, 2010
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: National Health and Medical Research Council
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Ministry of Health & Long Term Care, Ontario
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Denmark: The Ministry of the Interior and Health
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Korea: Food and Drug Administration
Netherlands: Medicines Evaluation Board (MEB)
Portugal: National Pharmacy and Medicines Institute
Sweden: The National Board of Health and Welfare
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Renal transplantation

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014