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

Novartis

Status and phase: Completed; Phase 2

Conditions: Renal Transplantation

Treatments: Drug: sotrastaurin (Dose 2) + tacrolimus + standard of care medications; Drug: sotrastaurin (Dose 1) + tacrolimus + standard of care medications; Drug: mycophenolic acid + tacrolimus + standard of care medications; Drug: sotrastaurin (Dose 3) + tacrolimus + standard of care medications

Study type: Interventional

Funder types: Industry

Identifiers

NCT01064791

CAEB071A2214

2009-015456-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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298 participants in 4 patient groups

Arm 1

Experimental group

Description:

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

Treatment:

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

Arm 2

Experimental group

Description:

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

Treatment:

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

Arm 3

Experimental group

Description:

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

Treatment:

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

Arm 4

Active Comparator group

Description:

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

Treatment:

Drug: mycophenolic acid + tacrolimus + standard of care medications