Renal Function Evaluation After Reduction of Cyclosporine A Dose in Renal Transplant Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

April 30, 2000

Primary Completion Date

November 30, 2006

Study Completion Date

November 30, 2006

Conditions
Kidney TransplantationPrimary PreventionKidney Failure
Interventions
DRUG

cyclosporine A

The usual-exposure level was based on the mean area-under-the-concentration-time curve (AUC0-12h). In the usual-exposure group, the cyclosporine AUC0-12h target was 4.3 (3.5 to 4.8, range) mg•h/L and in the low-exposure group the target was 50% or 2.2 (2.0 to 2.6, range) mg•h/L. Ranges were asymmetrical for safety reasons, i.e., to prevent the occurrence of rejection in the low-exposure arm and nephrotoxicity in the usual-exposure arm.The AUC 0-12h was estimated using a Bayesian estimator and a three-point limited sampling strategy (0, 1, and 3 hours). A computer program was used to calculate the dose adjustment required to reach the therapeutic target. Doses were adjusted in increments of 25% to reach the target within 2 months. Cyclosporine AUC0-12h was determined every 2 months.

All Listed Sponsors
lead

University Hospital, Rouen

OTHER

NCT00213590 - Renal Function Evaluation After Reduction of Cyclosporine A Dose in Renal Transplant Patients | Biotech Hunter | Biotech Hunter