39
Participants
Start Date
January 31, 2004
Primary Completion Date
September 30, 2006
Study Completion Date
June 30, 2008
Dose adaptation according to CN activity monitoring
The protocol of the CALCICLO trial consisted in a CsA dose adaptation during the first 100 days following transplantation. This dose adaptation was performed according to both residual CsA blood and CN activity levels only if the safety of vital functions - especially renal, liver, and neurological - was preserved as assessed by clinical evaluations and laboratory analyses such as creatinine clearance higher than 40 ml/min, serum bilirubin lower than 40 µM and absence of neurological signs. According to the protocol, CsA blood levels and CN activity were measured concomitantly at least once a week from day 0 to day 15, twice a week from day 16 to day 35 and then once a week until day 100.
Cyclosporine (CsA)
Cyclosporine (CsA)
Chu Henri Mondor, Créteil
Agence de La Biomédecine
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER