Renal allograft transplantation MedDRA version: 12.0 Level: LLT Classification code 10066543 Term: Acute allograft rejection
Conditions
Interventions
Product Name: Sotrastaurin 25 mg
Product Code: AEB071
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sotrastaurin
CAS Number: 425637-18-9
Current Sponsor code: AEB071
Other descriptive name:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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)).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate that at least one of the sotrastaurin treatment arms is non-inferior to the active control regimen myfortic + tacrolimus with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up) at Month 6 post-transplantation;Secondary Objective: • Evaluate renal function at Months 6, 12, 24 and 36 post-Tx using o eGFR by formula, o a composite renal function EP defined as eGFR-MDRD < 60 mL/min/1.73 m2 at Month 12, or a decrease from Month 3 to Month 12 = 10 mL/min/1.73 m2 in each sotrastaurin treatment arm relative to the control regimen (Month 12), o estimated creatinine clearance (Cockcroft-Gault formula). • Evaluate the composite efficacy endpoint in the sotrastaurin arms and the control arm at Months 12, 24 and 36 post-Tx. • Evaluate individual components (and combinations of the individual components) of the composite efficacy endpoint in the sotrastaurin arms and the control arm at Months 6, 12, 24 and 36 post-Tx. • Evaluate safety and tolerability between the sotrastaurin arms and the control arm, including infections, GI tolerability, ECG parameters, and hematological parameters (e.g. neutrophils) at Months 6, 12, 24 and 36 post-Tx.;Primary end point(s): The primary efficacy endpoint is defined as a composite of treated BPAR (tBPAR) of grade IA or higher, graft loss, death or lost to follow-up) based on the FAS. | — |
Countries
Belgium, Denmark, Germany, Hungary, Netherlands, Portugal, Sweden, United Kingdom
Outcome results
None listed