A partially blinded, prospective, randomized multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus vs. myfortic plus tacrolimus in de novo renal transplant recipients - A2214
- Conditions
- Renal allograft transplantationMedDRA version: 12.0Level: LLTClassification code 10066543Term: Acute allograft rejection
- Registration Number
- EUCTR2009-015456-14-HU
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
• Male or female patients = 18 years old.
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Recipients who are unable to receive the first dose of oral study medication within 24 hours after allograft reperfusion.
• 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 (unless lost due to surgical complication).
• Patients who are treated with drugs that are strong inducers or inhibitors of CYP3A4 at screening and cannot discontinue this treatment.
• Patients with long QT-syndrome, or QTcF at baseline exceeding 500 msec, or who are treated with drugs inducing QT prolongation at screening, and cannot discontinue this treatment.
• Patients requiring antiarrhythmic drugs with QT-prolonging properties (class 1a and class 3).
• Patients with a family history of long QT syndrome or of sudden unexplained death.
• Patients with a history, in the preceding 3 months of significant and persistent arrhythmias such as ventricular fibrillation or tachycardia, atrial fibrillation or flutter.
• Patients with symptomatic/unstable coronary artery disease (i.e. angina, untreated cardiac atherosclerotic disease) requiring hospitalization or a revascularization procedure in the 30 days prior to randomization.
• Patients with chronic heart failure which required hospitalization in the 30 days prior to randomization.
• Patients at high immunological risk, e.g., sensitized patients (most recent anti-HLA class I panel reactive antibodies (PRA) > 20% by a CDC-based assay or > 50% by a flow cytometry, Luminex or enzyme linked immunosorbant assay (ELISA)).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method