Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
NCT01064791 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 298
Last updated 2020-12-22
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
- 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
-
Novartis Pharmceuticals · Novartis Pharmceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2012-08-31
- Completion
- 2012-08-31
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Colombia
- Denmark
- Germany
- Hungary
- Netherlands
- Portugal
- South Korea
- Sweden
- United Kingdom
Study Locations
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