renal transplantation
Conditions
Interventions
Product Name: AEB071
Product Code: AEB071
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sotrastaurin (proposed)
CAS Number: 425637-18-9
Current Sponsor code: AEB071
Concentration unit: mg mi
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients = 18 years old. • Recipients of a primary kidney transplant from a deceased, living unrelated or non-HLA identical living related donor. • Recipients of a kidney with a CIT =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Multi-organ transplant recipients or if the patient previously received an organ transplant. • Recipients of an organ from a non-heart beating donor. • Patients who are recipients of A-B-O incompatible transplants, all CDC cross-match positive transplants. • Patients without functional graft 24h after graft reperfusion (functional graft being defined as urine output of more than 250 mL/12h for patients without residual urinary output from native kidneys, or as a decrease in serum creatinine by at least 20% from pre-transplant). • Patients with a platelet count 500 ms, long QT syndrome (own or with a family history) or with a family history of sudden unexplained death. • Patients with LBBB or who experienced, during the previous 6 months, hospitalisation for heart failure of cardiac etiology, or significant and persistant left-ventricular dysfunction (LVEF 20% by a CDC-based assay or > 50% by a flow cytometry or ELISA-based assay) or patients identified otherwise to be at high immunological risk. • History of malignancy of any organ system, treated or untreated, within the past 5 years regardless of evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin (excised = 2 years prior to randomization). • Patients with severe systemic infections, current or within the 2 weeks prior to randomization. • Patients with any history of significant coagulopathy or medical condition requiring long-term systemic anticoagulation after transplantation, which would interfere with obtaining biopsies. Low dose aspirin treatment (up to 200 mg/day) is allowed. (Plavix® is not allowed). • Evidence of severe liver disease, including abnormal liver profile (AST, ALT or total bilirubin > 3 times ULN) at screening. • Patients with BMI > 30. • Patients who have severe hypercholesterolemia (> 350 mg/dL; > 9 mmol/L) or hypertriglyceride
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The composite efficacy failure end point treated BPAR, graft loss, death or loss to follow-up.;Main Objective: The primary objective of the study is to compare, in Stage 1, the efficacy of AEB071 to that of Neoral, both in combination with Certican, Simulect, and steroids, at 3 months after transplantation. Efficacy will be defined using a composite efficacy failure end point (treated BPAR, graft loss, death or loss to follow-up). • TO COMPARE, in Stage 2, the efficacy of each AEB071 treatment regimen (AEB071 200 mg bid or 300 mg bid in combination with Certican, Simulect, and steroids) with the control regimen (Neoral in combination with Certican, Simulect, and steroids), at Month 6. ;Secondary Objective: Main secondary efficacy objective: • To compare the composite efficacy failure endpoint (treated BPAR, graft loss, or death) of each AEB071 treatment regimen with the control regimen (Certican + Neoral) in each Stage (Stage 1 and Stage 2) at Months 3, 6 and 12. Main safety objective: • To determine the dose or concentration of AEB071 and Certican with the best benefit/risk profile to be used in Phase III trials. • To compare the composite efficacy failure endpoint (treated BPAR, graft loss, death, or loss to follow-up) of each AEB071 treatment regimen with the control regimen in Stage 1 at Months 6 and 12, and in Stage 2 at Months 3 and 12. | — |
Countries
Austria, Czech Republic, France, Germany, Italy, Netherlands, Slovakia
Outcome results
None listed