VIP: Vascular Imaging Project. Study on the Progression of Cardiovascular Disease in Renal Transplant Recipients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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 mycophenolate mofetil (MMF) on the progression of subclinical cardiovascular disease in renal transplant recipients.

Since CNI have a detrimental effect on cardiovascular risk factors, it is the researchers' hypothesis that renal recipients after CNI withdrawal will have more reduction of markers of cardiovascular disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Calcineurin Inhibitors; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , MMF and steroids

• Informed consent

Exclusion Criteria:

• 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.