CClinicalTrials.gg
Sign In
CompletedNCT00169910Updated Dec 17, 2012

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

A Phase 4 interventional study of AUC monitored withdrawal of MMF or CNI in Cardiovascular Disease, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-17.

Sponsored by Leiden University Medical Center · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Cardiovascular Disease

Keywords

  • Renal Transplantation
  • Calcineurin Inhibitor
  • Mycophenolate Mofetil
  • Cardiovascular Disease
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 119 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , MMF and steroids
  • Informed consent

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
119 participants (actual)

Study arms

  • Active comparator
    1

    AUC monitored withdrawal of MMF

    Drug: AUC monitored withdrawal of MMF or CNI

  • Active comparator
    2

    AUC monitored withdrawal of CNI

    Drug: AUC monitored withdrawal of MMF or CNI

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

06

What researchers measure

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

07

Study locations

1 site
  • Leiden University Medical Center
    Leiden, 2300 RC, Netherlands
08

References and documents

Publications

  • Schnuelle P, van der Heide JH, Tegzess A, Verburgh CA, Paul LC, van der Woude FJ, de Fijter JW. Open randomized trial comparing early withdrawal of either cyclosporine or mycophenolate mofetil in stable renal transplant recipients initially treated with a triple drug regimen. J Am Soc Nephrol. 2002 Feb;13(2):536-543. doi: 10.1681/ASN.V132536. PubMed 11805185 ↗
  • O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22. doi: 10.1056/NEJM199901073400103. PubMed 9878640 ↗
  • Blacher J, Guerin AP, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness on survival in end-stage renal disease. Circulation. 1999 May 11;99(18):2434-9. doi: 10.1161/01.cir.99.18.2434. PubMed 10318666 ↗
  • Mourer JS, de Koning EJ, van Zwet EW, Mallat MJ, Rabelink TJ, de Fijter JW. Impact of late calcineurin inhibitor withdrawal on ambulatory blood pressure and carotid intima media thickness in renal transplant recipients. Transplantation. 2013 Jul 15;96(1):49-57. doi: 10.1097/TP.0b013e3182958552. PubMed 23715049 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00169910
Lead sponsor
Leiden University Medical Center
Responsible party
J.S.Mourer (MD, Leiden University Medical Center) — Principal investigator
First posted
Sep 15, 2005
Start date
Dec 2005
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Dec 17, 2012

Study contacts

Johan W. de Fijter, MD,PhD
study chair · Leiden University Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cardiovascular Diseases→

Other studies from this sponsor

Leiden University Medical Center

Start the discussion