NCT00169910

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	AUC 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

Timeline

• Start date: 2005-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2005-09-15
• Last updated: 2012-12-17

Locations

1 site across 1 country: Netherlands