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

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: AUC monitored withdrawal of MMF or CNI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>AUC monitored withdrawal of MMF | Drug: AUC monitored withdrawal of MMF or CNI<br>* AUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients<br>|
| Active Comparator: 2<br>AUC monitored withdrawal of CNI | Drug: AUC monitored withdrawal of MMF or CNI<br>* AUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Transplantation, Calcineurin Inhibitor, Mycophenolate Mofetil, Cardiovascular Disease