LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant

LOW CYCLO: A Multicenter, Prospective, Randomized Study Evaluating the Benefit, on Renal Function, of Two Doses of Ciclosporine: Low Dose Versus Usual Dose, in Association With Mycophenolate and Corticoïds, in de Novo Cardiac Transplant

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.

Inclusion Criteria:

Recipient:

• Males or females, ages > 18 < 65.
• First cardiac transplant.
• Negative pregnancy test for females of childbearing potential, at screening. Efficient method of contraception must be used during the study.
• Written informed consent.

Donor:

• Cold ischemia duration < 6 hours

Exclusion Criteria:

Recipient:

• Unstable hemodynamic status at randomization.
• Patient with assisted circulation, considered unstable.
• Serum creatinine > 250 µmol/l.
• Nursing or pregnant females.
• HIV positive.
• PCR hepatitis C virus (HCV) positive or hepatitis B surface (Hbs) antigen positive (within 6 months prior to study).
• Multi-organ graft or retransplant.
• History of cancer (evolving, or within 5 years, except for epidermoid or basocellular localised cutaneous carcinoma).
• Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry.
• Any substance abuse or any psychiatric disorder
• Contra-indication to study treatments.
• Unable to introduce ciclosporine within 4 days after transplant.

Donor:

• Known coronary pathology or cardiac disease.
• HBsAg positive or HCV positive