NCT01064791

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	sotrastaurin (Dose 1) + tacrolimus + standard of care medications	sotrastaurin (100mg bid) + tacrolimus + standard of care medications
DRUG	sotrastaurin (Dose 2) + tacrolimus + standard of care medications	sotrastaurin (200mg bid) + tacrolimus + standard of care medications
DRUG	sotrastaurin (Dose 3) + tacrolimus + standard of care medications	sotrastaurin (300mg bid) + tacrolimus + standard of care medications
DRUG	mycophenolic acid + tacrolimus + standard of care medications	mycophenolic acid (720mg bid) + tacrolimus + standard of care medications

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-02-08
• Last updated: 2020-12-22

Locations

44 sites across 15 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Germany, Hungary, Netherlands, Portugal, South Korea, Sweden, United Kingdom