LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Primary Objective:
- Evaluation of the benefit on renal function of one year of a low dose of ciclosporine
versus the usual dose
Secondary Objective:
- To evaluate the immunosuppressive efficacy and tolerance of the treatment
Study Duration:
Twelve months for each patient
Study Treatment: Ciclosporine
Group A: low dose >= 130 µg/l < T0 ciclosporinemia < 200 µg/l; Group B: standard dose >= 200
µg/l < T0 ciclosporinemia < 300 µg/l.
Study Visits:
One visit every 15 days, for the first three months; then 1 visit every month, for 6 months;
and 1 visit at 9 and 12 months.
Associated Treatments:
- Mycophenolate (Cellcept®), 3g a day
- Corticoids, as used for transplanted patients
Randomization: Randomization will occur when it is decided that ciclosporine will be
introduced.