Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT00159159
Brief 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.
Study:
NCT00159159
Study Brief:
Protocol Section:
NCT00159159