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

Sponsored by:	Leiden University Medical Center
Information provided by:	Leiden University Medical Center
ClinicalTrials.gov Identifier:	NCT00169910

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Disease	Drug: AUC monitored withdrawal of MMF or CNI	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official 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.

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:

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: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary endpoint: Cardiovascular risk factors: a) Hypertension, b) Hyperlipidemia, c) Diabetes mellitus/glucose intolerance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Graft function [ Time Frame: 1 year, 5 years ] [ Designated as safety issue: Yes ]
Incidence of acute rejection [ Time Frame: 1 year, 5 years ] [ Designated as safety issue: Yes ]
Graft survival (creatinine clearance < 15 ml/min or dialysis) [ Time Frame: 1 year, 5 years ] [ Designated as safety issue: Yes ]
Patient survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment:	119
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator AUC monitored withdrawal of MMF	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
2: Active Comparator AUC monitored withdrawal of CNI	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

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 5 years and the target sample size is 100 patients per arm

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169910

Locations

Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC

Sponsors and Collaborators

Leiden University Medical Center

Investigators

Study Chair:

Ton Rabelink, MD,PhD

Leiden University Medical Center

More Information

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):536-43.

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.

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.

Responsible Party:	Leiden University Center ( Johan W. de Fijter MD PhD )
Study ID Numbers:	P05.105
Study First Received:	September 9, 2005
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00169910
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:

Renal Transplantation
Calcineurin Inhibitor
Mycophenolate Mofetil
Cardiovascular Disease

Study placed in the following topic categories:

Mycophenolate mofetil
Disease Progression

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Cardiovascular Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009