NCT00169910|CompletedPhase 4
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Sponsor study identifier
interventional
119
1 country
1
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2005
Actual (reported)September 15, 2005
Actual (reported)December 2005
Date type not reportedThis date has not been verified as actual or estimated.
December 2010
Actual (reported)December 2010
Actual (reported)Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH)
3 years
Secondary endpoint: Cardiovascular risk factors: a) Hypertension, b) Hyperlipidemia, c) Diabetes mellitus/glucose intolerance
3 years
Graft function
1 year, 3 years
Incidence of acute rejection
1 year, 3 years
Graft survival (creatinine clearance < 15 ml/min or dialysis)
1 year, 3 years
Patient survival
3 years
AUC monitored withdrawal of MMF
AUC monitored withdrawal of CNI
AUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Leiden University Medical Center
Leiden, 2300 RC, Netherlands
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.
Johan W. de Fijter, MD,PhD
Leiden University Medical Center
119 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery
Contact the study team to confirm eligibility.
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.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
December 17, 2012
Record last verified: 2012-12
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Source: ClinicalTrials.gov.
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