Heart transplantation or lung transplantation
Conditions
Sponsors
Novartis Nordic Countries, Business Unit Transplantation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patient at least 18 years of age. Patient who have undergone a heart or lung transplantation more than 12 months ago. Patient receiving Neoral® or Prograf®. Patients with a measured or calculated GFR > 20 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient who is recipient of multiple organ transplants. Patient with measured or calculated GFR 70 mL/min/1,73m2. Patient with a treated acute rejection episode within the last 3 months. Patient with a platelet count of < 50,000/mm3 or with a white blood cell count of = 2,500/mm3 or with a hemoglobin value < 8 g/dL. Presence of severe hypercholesterolemia (= 8,0 mmol/L) or hypertriglyceridemia (= 6,0 mmol/L) despite conventional lipid lowering treatment. Patient being currently treated or who has been treated with a mTOR inhibitor. Patient who had received an investigational drug within 4 weeks. Patient who is human immunodeficiency virus positive or who has a current severe systemic infection according to the investigator judgment requiring continued therapy. Present use of any other immunosuppressive drugs than Neoral®/Prograf® , MPA/AZA and steroids. Patients with a known hypersensitivity to drugs similar to everolimus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment will improve renal function. This will be assessed by comparing renal function assessed by measured glomerular filtration rate (mGFR) between the treatment groups, using the change from baseline to Month 12 of treatment.;Secondary Objective: To compare: • number and severity of treated biopsy proven acute rejections • number of treated acute rejections • patient and graft survival • slopes of reciprocal serum creatinine (1/Cr) and slope of change of calculated GFR levels over study duration • safety parameters (incidence of hypertension, hyperlipidemia, diabetes mellitus, anemia, thrombocytopenia, malignancies and infections) • number of patients in need of dialysis during the study • health economy data measured as average total days of hospitalization between the groups • number of treatment failures • intima media thickness changes of coronary artery by intravascular ultrasound • the incidence or worsening of bronchiolitis obliterans syndrome • changes in lung function (lung transplant recipients) • the incidence of major adverse cardiovascular events (heart transplant recipients) • left ventricular function (heart transplant recipients) ;Primary end point(s): The primary objective will be assessed by comparing renal function assessed by measured glomerular filtration rate (mGFR), using the change from baseline to month 12 of treatment, between the 2 groups of patients: • Group A: current immunosuppressive regimen continuation (Control arm) • Group B: initiation of everolimus (3-8 ng/mL) with reduction of CNI (Test arm) That is, the primary objective is to show either Group B will be superior to control Group A with respect to mean mGFR change from baseline to month 12 of treatment | — |
Countries
Sweden
Contacts
Public ContactBusiness Unit Transplantation
Novartis Nordic Countries, Business Unit Transplantation
Outcome results
None listed