Status:
COMPLETED
Renal Function Evaluation After Reduction of Cyclosporine A Dose in Renal Transplant Patients
Lead Sponsor:
University Hospital, Rouen
Conditions:
Kidney Transplantation
Primary Prevention
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 rena...
Detailed Description
Study population Eligible patients were 18 to 75 years of age and primary or secondary renal transplant recipients in their second year posttransplant with stable serum creatinine levels (i.e., \< 20%...
Eligibility Criteria
Inclusion
- 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
- 2 or more acute rejection episodes
- PRA\> 80%
- serum creatinine\> 250µmol/L
- 24-hour proteinuria \> 1g
- humoral rejection
- vasculitis
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00213590
Start Date
April 1 2000
End Date
November 1 2006
Last Update
February 16 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.