Heart-Lung, bilateral lung and single lung transplant recipients ICD Classification: K01-K01.9, E53.9+Z94.1, E53.9+Z94.2, E53.9+Z94.3
Conditions
Interventions
Trade Name: Certican
Pharmaceutical Form: Tablet
Trade Name: Myfortic
Pharmaceutical Form: Tablet
Sponsors
St Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female recipients of a first heart-lung, bilateral lung or single lung allograft who are suitable to receive everolimus or mycophenolate sodium plus cyclosporin and corticosteroid triple therapy. Patients between 18 and 65 years. Patients capable of understanding the purposes and risks of the study and who have given informed written consent. Male and female patients of childbearing age agree to maintain effective birth control practice during the study and for 3 months after cessation. 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
Exclusion criteria
Exclusion criteria: Patients who require immunosuppressive therapy other than study medication. Patients receiving a lobar lung transplant from a living donor. Patients who have received a prior lung or other organ transplant. Pregnant women, nursing mothers. Women unwilling to use adequate contraception during and for 3 months following the conclusion of treatment with study drug. Patients or their donors with serologic evidence of, HIV, HbsAg or HCV antibodies. Patients with malignancies or history of malignancy with a recurrence free interval of <5 years except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. Patients with systemic infections requiring therapy at the time of entry into the study. A systemic infection is defined as a body temperature of 380C or above on 2 occasions, or 390C accompanied by a culture of body fluid regarded as significant by the local laboratory and requiring antibiotic therapy. Patients with panresistant infections with Burkholderia cepacia or mycobacteria in the last year. Patients with renal insufficiency (creatinine clearance < 50 ml/min). Patients with severe uncontrolled hypercholesterolemia (³ 350 mg/dL, 9.1 mmol/L) or hypertriglyceridemia (³ 750 mg/dL, 8.5 mmol/L). Patients with a white blood cell count of < 2,500/mm3 or platelet count < 50,000/mm3. Presence of any severe allergy requiring acute or chronic treatment, or hypersensitivity to drugs similar to RAD (e.g., erythromycin or other macrolide antibiotics) or to Myfortic. Patients on invasive ventilator devices or extracorporeal membrane oxygenators (ECMO).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : to assess the efficacy and safety of delayed onset Certican (Everolimus) compared to Myfortic (enteric coated Mycophenolate Sodium: MPS), both arms in combination with Cyclosporin A (CsA)(monitored by C2 levels) and corticosteroids for the prevention of chronic rejection (Bronchiolitis Obliterans Syndrome: BOS) in the first 3 years post transplant when given as de novo maintenance therapy for the management of lung allograft recipients after bronchial anastomotic healing has been confirmed at bronchoscopy;Secondary Objective: Secondary objectives : to assess the efficacy and safety of the administration of Certican (Everolimus). This will be measured at 12 months by the comparison between treatment arms of incidence of BOS, incidence of obliterative bronchiolitis, death rate, incidence of premature study discontinuation and study treatment discontinuation, incidence of Serious Adverse Events (SAE) and incidence of Adverse Events (AE). In addition the number and severity of acute rejection episodes per patient and per hundred patient days will be assessed plus the proportion of patients with at least one rejection episode and the time to first rejection. A composite vascular rejection score will be established as the sum of A grades divided by the postoperative survival in days. A composite bronchial rejection score will be established as the sum of B grades divided by the postoperative survival in days.;Primary end point(s): Development of BOS, 3 years after transplantation | — |
Countries
Austria, Germany, Spain, United Kingdom
Outcome results
None listed