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OpenTrials
Completed

NCT Number: NCT01064791

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

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Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Corrientes, 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 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

Treatment and study plan

sotrastaurin (Dose 1) + tacrolimus + standard of care medications

Drug

sotrastaurin (100mg bid) + tacrolimus + standard of care medications

sotrastaurin (Dose 2) + tacrolimus + standard of care medications

Drug

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

sotrastaurin (Dose 3) + tacrolimus + standard of care medications

Drug

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

mycophenolic acid + tacrolimus + standard of care medications

Drug

mycophenolic acid (720mg bid) + tacrolimus + standard of care medications

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 8, 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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