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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01064791

Enrollment

298

Registered

2010-02-08

Start date

2009-12-31

Completion date

2012-08-31

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Keywords

Renal transplantation

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.

Interventions

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

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

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

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

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

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

DRUGmycophenolic acid + tacrolimus + standard of care medications

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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).	Month 6

Secondary

Measure	Time frame
Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine)	Months 6, 12, 24, and 36
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).	Months 12, 24, and 36
Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).	Months 6, 12, 24, and 36
Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).	Months 6, 12, 24, and 36

Countries

Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Germany, Hungary, Netherlands, Portugal, South Korea, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026