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

VIP: Vascular Imaging Project. Prospective Randomized Study on the Effect of AUC-monitored Treatment With Steroids Combined With Either a Calcineurin Inhibitor or Mycophenolate Mofetil on the Progression of Subclinical Cardiovascular Disease in Renal Transplant Recipients.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169910

Enrollment

119

Registered

2005-09-15

Start date

2005-12-31

Completion date

2010-12-31

Last updated

2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Renal Transplantation, Calcineurin Inhibitor, Mycophenolate Mofetil, Cardiovascular Disease

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 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.

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 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

Interventions

DRUGAUC monitored withdrawal of MMF or CNI

AUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH)	3 years

Secondary

Measure	Time frame
Secondary endpoint: Cardiovascular risk factors: a) Hypertension, b) Hyperlipidemia, c) Diabetes mellitus/glucose intolerance	3 years
Graft function	1 year, 3 years
Incidence of acute rejection	1 year, 3 years
Graft survival (creatinine clearance < 15 ml/min or dialysis)	1 year, 3 years
Patient survival	3 years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026