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

Hospices Civils de Lyon · 2004
ClinicalTrials.gov · Datasets · License: Public Domain · 2004
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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 \= 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.
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