prophylaxis of liver allograft rejection in liver transplant recipients MedDRA version: 12.1 Level: LLT Classification code 10066543 Term: Acute allograft rejection
Conditions
Interventions
Trade Name: Certican
Product Code: RAD001
Pharmaceutical Form: Tablet
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability and willingness to provide written informed consent before any assessment is performed; 2. Ability and willingness to adhere to study regimen; 3. Completed Month 24 visit of core study and continuously treated with assigned regimen. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have uncontrolled, severe hypercholesterolemia or hypertriglyceridemia; 2. Patients with platelet count <50,000/mm3; 3. Patients with an absolute neutrophil count of <1,000/mm³ or white blood cell count of <2,000/mm³; 4. Patients who have tested positive for human immunodeficiency virus (HIV); 5. Patients with clinically significant systemic infection requiring use of IV antibiotics; 6. Patients who are in a critical care setting requiring life support measures; 7. Use of prohibited medication; 8. Use of immunosuppressive agents or treatments not utilized in the protocol; 9. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes; 10. Pregnant or nursing (lactating) women; 11. Women of child-bearing potential not using highly effective methods of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate at Month 36 & 48 post-transplantation: - renal function; - composite efficacy endpoint of graft loss and death; - composite efficacy endpoint of treated biopsy proven acute rejection (BPAR), graft loss, or death; - rates of progression of HCV related allograft fibrosis. ;Secondary Objective: To evaluate at Months 36 and 48 post-transplantation: - treated BPAR; - Evolution of renal function/CNI-related side effects as defined by eGFR, hypertension, neurotoxicity, new onset diabetes; - Study-/ Study-Drug related findings as defined by premature discontinuation of study medication, premature discontinuation from the study, dose interruption, dose reduction of study medication, adverse events and serious adverse events, infections, major adverse cardiac events (MACE). - Evolution of HCV and HCV related fibrosis as defnied by HCV viral load (HCV-RNA levels) and progression of HCV fibrosis - rate of recurrence of hepatocellular carcinoma (HCC) in patients with a diagnosis of HCC prior to liver transplantation And fo describe the change in patterns of specific biomarkers for renal injury in the urine throughout the study;Primary end point(s): Variable 1: Renal function measured by eGFR as calculated using the MDRD-4 formula at Month 36 post-transplantation; Variable 2: Composite efficacy endpoint of graft loss and death at Month 36 & 48; Variable 3: Composite efficacy endpoint of treated BPAR, graft loss, or death at Month 36; Variable 4: Clinically meaningful progression of HCV related allograft fibrosis at Month 36, defined as progression by at least 1 grade in the Ishak-Knodell score from extension baseline to Month 36. | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed