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

Leiden University Medical Center (LUMC)

Status and phase

Completed

Phase 4

Conditions

Cardiovascular Disease

Treatments

Drug: AUC monitored withdrawal of MMF or CNI

Study type

Interventional

Funder types

Other

Identifiers

NCT00169910

P05.105

Details and patient eligibility

About

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.

Full 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 of either CNI or MMF.

The progression of cardiovascular markers will be assessed by yearly measurements of Intima Media Thickness, Pulse Wave Velocity and Left Ventricular Hypertrophy in both groups.

The duration of the study will be 3 years and the target sample size is 100 patients per arm

Enrollment

119 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.