Status:
COMPLETED
VIP: Vascular Imaging Project. Study on the Progression of Cardiovascular Disease in Renal Transplant Recipients
Lead Sponsor:
Leiden University Medical Center
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective randomized study to compare the influence of area under the curve (AUC)-monitored dual treatment with steroids in combination with either a calcineurin inhibitor (CNI) or mycophe...
Detailed Description
Stable renal transplant patients on maintenance immunosuppressive therapy with steroids, a calcineurin inhibitor (CNI) and mycophenolate mofetil (MMF) will be randomized for AUC-monitored withdrawal o...
Eligibility Criteria
Inclusion
- Patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , MMF and steroids
- Informed consent
Exclusion
- Calculated creatinine clearance \< 30 ml/min
- Multi-organ recipients
- Patients with a (historic) panel reactive antibody (PRA) \>60%
- Third renal transplant or more.
- Patients receiving investigational drugs other than MMF in combination with cyclosporine or tacrolimus
- Solid malignancy, post-transplant lymphoproliferative disease.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00169910
Start Date
December 1 2005
End Date
December 1 2010
Last Update
December 17 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Leiden University Medical Center
Leiden, Netherlands, 2300 RC