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

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ClinicalTrials.gov Identifier: NCT01064791
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 renal transplantation.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination). [ Time Frame: Months 6, 12, 24, and 36 ]


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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 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


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): NCT01064791


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

Additional Information:
Publications of Results:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01064791     History of Changes
Other Study ID Numbers: CAEB071A2214
2009-015456-14 ( EudraCT Number )
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Renal transplantation

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