CeMyLungs
A 3 year randomised, open label, multi-centre Investigator driven study comparing de Novo enteric coated Mycophenolate Sodium with delayed onset Everolimus, both arms in combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant recipients.
Professor Allan R. Glanville
320 participants
Aug 3, 2005
Interventional
Conditions
Summary
To assess the efficacy and safety of delayed onset Certican (Everolimus) compared to Myfortic (enteric coated Mycophenolate Sodium: MPS), both arms in combination with Cyclosporin A (CsA)(monitored by C2 levels) and corticosteroids for the prevention of chronic rejection (Bronchiolitis Obliterans Syndrome: BOS) in the first 3 years post transplant when given as de novo maintenance therapy for the management of lung allograft recipients after bronchial anastomotic healing has been confirmed at bronchoscopy.
Eligibility
Plain Language Summary
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Interventions
Following bronchoscopic confirmation of bronchial anastomotic healing, the patients will be randomised to either continue Mycophenolate Sodium 1080mg BD, in combination with Cyclosporin and corticosteroids or switched to receive Everolimus (initial dose 1.5mg Bd), then dose adjusted on trough levels in combination with Cyclosporin and Corticosteroids. This treatment will continue for 3 years post transplantation.
Locations(1)
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ACTRN12605000141640