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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to show the efficacy of reduction of cyclosporine A exposure measured by the area under the curve by Bayesian estimator on the primary prevention of degradation of the renal function in renal transplant recipients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Rouen
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• first or second renal graft

• cadaveric renal graft

• second year of renal transplantation

• stable renal function

• moderate renal dysfunction risk

• bitherapy with cyclosporine A and mycophenolate mofetil

• corticosteroid withdrawal since 3 months at less

Exclusion Criteria:

• 2 or more acute rejection episodes

• PRA> 80%

• serum creatinine> 250µmol/L

• 24-hour proteinuria > 1g

• humoral rejection

• vasculitis