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

Phase 4

Completed

• Conditions: Cardiovascular Disease
• Interventions: Drug: AUC monitored withdrawal of MMF or CNI

• Registration Number: NCT00169910
• Lead Sponsor: Leiden University Medical Center

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

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Study Start: 2005-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AUC monitored withdrawal of MMF or CNI	AUC monitored withdrawal of MMF
2	AUC monitored withdrawal of MMF or CNI	AUC monitored withdrawal of CNI

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Graft survival (creatinine clearance < 15 ml/min or dialysis)	1 year, 3 years
Patient survival	3 years
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

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands