Kidney Transplantation Clinical Trial
— DICAMOfficial title:
A Multicentric, Randomized, Opened Study to Evaluate Efficacy on Renal Function of an Immunosuppressant Regimen Based on Cyclosporine A Dose Reduction in Combination With Mycophenolate Mofetil, From the Second Year of Renal Transplantation
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
Status | Completed |
Enrollment | 208 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | renal function at two years | every two months | Yes | |
Secondary | proteinuria | every two months | No | |
Secondary | hypertension | every two months | No | |
Secondary | hemodialysis | at any time during the study period | Yes | |
Secondary | nephrotoxicity | at any time during the study period | No | |
Secondary | chronic renal dysfunction | at two years | No | |
Secondary | biopsy proven late acute rejection | at any time during the study period | Yes | |
Secondary | dyslipidemia | every six months | No | |
Secondary | patient survival | at two years | Yes | |
Secondary | graft survival | at two years | Yes | |
Secondary | severe infection with hospitalisation | at any time during the study period | Yes | |
Secondary | post transplant lymphoproliferative disorder | at any time during the study period | Yes | |
Secondary | cutaneous carcinoma | every year | Yes | |
Secondary | area under the concentration-time of cyclosporine A | every two months | No | |
Secondary | area under the concentration-time of mycophenolate mofetil | at month 0 6 12 and 24 | No | |
Secondary | biodisponibility of mycophenolate mofetil after reduction of cyclosporine A exposure | at month 6 12 and 24 | No |
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