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

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.

Timeline

Start

2004-03

Primary completion

—

Completion

—

Publications

• Boissonnat P, Gaillard S, Mercier C, Redonnet M, Lelong B, Mattei MF, Mouly-Bandini A, Pattier S, Sirinelli A, Epailly E, Varnous S, Billes MA, Sebbag L, Ecochard R, Cornu C, Gueyffier F. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial. Trials. 2012 Dec 3;13:231. doi: 10.1186/1745-6215-13-231.

Drugs

Indications

No indication recorded.