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Completed

NCT Number: NCT00169910

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AUC monitored withdrawal of MMF or CNI

Drug

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

Primary outcomes

  1. Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH)

    Time frame: 3 years

Secondary outcomes

  1. Secondary endpoint: Cardiovascular risk factors: a) Hypertension, b) Hyperlipidemia, c) Diabetes mellitus/glucose intolerance

    Time frame: 3 years

  2. Graft function

    Time frame: 1 year, 3 years

  3. Incidence of acute rejection

    Time frame: 1 year, 3 years

  4. Graft survival (creatinine clearance < 15 ml/min or dialysis)

    Time frame: 1 year, 3 years

  5. Patient survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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.

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 15, 2005
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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