VIP: Vascular Imaging Project. Study on the Progression of Cardiovascular Disease in Renal Transplant Recipients
NCT ID: NCT00169910
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
119 participants
INTERVENTIONAL
2005-12-31
2010-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
AUC monitored withdrawal of MMF
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
AUC monitored withdrawal of CNI
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Informed consent
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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J.S.Mourer
MD
Principal Investigators
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Johan W. de Fijter, MD,PhD
Role: STUDY_CHAIR
Leiden University Medical Center
Locations
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Leiden University Medical Center
Leiden, , Netherlands
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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P05.105
Identifier Type: -
Identifier Source: org_study_id