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

Completed · Phase 2

Conditions studied: Renal Transplantation

In brief

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.

Key facts

Study ID

NCT01064791

Run by

Novartis Pharmaceuticals

People needed

298

Starts

2009-12-01

Expected to finish

2012-08-01

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Madison, Wisconsin, United States
• Novartis Investigative Site — Corrientes, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Camperdown, New South Wales, Australia
• Novartis Investigative Site — Woolloongabba, Queensland, Australia
• Novartis Investigative Site — Adelaide, South Australia, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Cali, Colombia
• Novartis Investigative Site — Aarhus, Denmark
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Cologne, Germany

Full record on ClinicalTrials.gov

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