Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy
NCT ID: NCT00966836
Last Updated: 2009-08-27
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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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2009-04-30
Brief Summary
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Two strategies involving administration of specific anti-CMV agents are recommended for prevention of CMV infection/disease: universal prophylaxis and preemptive therapy. The pros and cons of the two strategies are still debated, in the absence of randomized studies addressing graft-related outcomes and viral mechanisms of graft damage, and without any clear evidence of superiority of either approach.
The investigators conceived this randomized prospective project to compare the effect of preemptive anti-CMV strategy with universal anti-CMV prophylaxis on CMV infection and on one-year increase in coronary intimal thickening. Patients will be additionally randomized to receive either mycophenolate mofetil or everolimus, in light of the possible anti-CMV properties of everolimus.
Detailed Description
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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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Pre-emptive everolimus
Pre-emptive strategy with valganciclovir plus everolimus
Patients will be monitored for CMV infection and receive valganciclovir only for positive PCR or antigenemia. Everolimus plus cyclosporine and prednisone will be used for maintenance immunosuppression
Prophylaxis mycophenolate
Prophylaxis with valganciclovir plus mycophenolate
Patients will receive 3 months of oral valganciclovir with mycophenolate and standard cyclosporine and prednisone for maintenance immunosuppression
Prophylaxis Everolimus
Prophylaxis with valganciclovir plus everolimus
Patients will receive valganciclovir for 3 months after transplant. Everolimus plus reduced cyclosporine and prednisone will be used for maintenance immunosuppression
Pre-emptive mycophenolate
Pre-emptive mycophenolate
Patients will be monitored for CMV infection and receive valganciclovir only for positive PCR or antigenemia. Mycophenolate plus standard cyclosporine and prednisone will be used for maintenance immunosuppression
Interventions
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Pre-emptive strategy with valganciclovir plus everolimus
Patients will be monitored for CMV infection and receive valganciclovir only for positive PCR or antigenemia. Everolimus plus cyclosporine and prednisone will be used for maintenance immunosuppression
Prophylaxis with valganciclovir plus mycophenolate
Patients will receive 3 months of oral valganciclovir with mycophenolate and standard cyclosporine and prednisone for maintenance immunosuppression
Prophylaxis with valganciclovir plus everolimus
Patients will receive valganciclovir for 3 months after transplant. Everolimus plus reduced cyclosporine and prednisone will be used for maintenance immunosuppression
Pre-emptive mycophenolate
Patients will be monitored for CMV infection and receive valganciclovir only for positive PCR or antigenemia. Mycophenolate plus standard cyclosporine and prednisone will be used for maintenance immunosuppression
Eligibility Criteria
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Inclusion Criteria
* Heart or heart-kidney combined transplant
* Positive CMV serology at the time of transplant
* Glomerular filtration rate ≥ 20 ml/min/1.73m2 with MDRD at randomization.
* Written informed consent
Exclusion Criteria
* Less than 1000/mmc neutrophils at the time of randomization
* Less than 30,000/mmc platelets at the time of randomization
* Clinical significant infection in the 2 weeks prior to transplant
* Glomerular filtration rate \< 20 ml/min/1.73m2 estimated with MDRD formula at the time of randomization or hemodialysis treatment
* Intolerance towards valganciclovir, everolimus, mycophenolate or cyc-losporine
* Known contraindication to statin use
* Negative CMV serology at the time of transplant
* HIV positive testing
* Severe comorbidities that, based on investigator's judgment, contraindicate study drugs or procedures
* Potentially childbearing women who refuse to use contraceptives
* Participation to an interventional study in the 2 preceding weeks
* Unwillingness or inability to follow study procedure and to sign written in-formed consent
18 Years
70 Years
ALL
No
Sponsors
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University of Bologna
OTHER
Responsible Party
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University of Bologna
Locations
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Azienda Ospedaliero-Universitaria S Orsola Malpighi
Bologna, , Italy
Countries
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Central Contacts
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References
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Potena L, Grigioni F, Magnani G, Lazzarotto T, Musuraca AC, Ortolani P, Coccolo F, Fallani F, Russo A, Branzi A. Prophylaxis versus preemptive anti-cytomegalovirus approach for prevention of allograft vasculopathy in heart transplant recipients. J Heart Lung Transplant. 2009 May;28(5):461-7. doi: 10.1016/j.healun.2009.02.009.
Potena L, Valantine HA. Cytomegalovirus-associated allograft rejection in heart transplant patients. Curr Opin Infect Dis. 2007 Aug;20(4):425-31. doi: 10.1097/QCO.0b013e328259c33b.
Hill JA, Hummel M, Starling RC, Kobashigawa JA, Perrone SV, Arizon JM, Simonsen S, Abeywickrama KH, Bara C. A lower incidence of cytomegalovirus infection in de novo heart transplant recipients randomized to everolimus. Transplantation. 2007 Dec 15;84(11):1436-42. doi: 10.1097/01.tp.0000290686.68910.bd.
Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
Other Identifiers
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PROTECT 2008-006980-35
Identifier Type: -
Identifier Source: org_study_id