A Phase 4 interventional study of everolimus and azathioprine or mycophenolate mofetil in Cardiac Transplant, sponsored by Fundacion Investigacion y Desarrollo. Status unknown at 8 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-01-30.
Sponsored by Fundacion Investigacion y Desarrollo · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate if there is a significantly less incidence of major clinical events due to graft vascular illness in recipients of a cardiac transplant on treatment with an immunosuppressive combination, which includes Everolimus, compared to those that continue the previously used immunosuppressive treatment.
This is a prospective, randomized, multicentre, open and controlled study, to evaluate the efficacy and safety of everolimus combined with cyclosporin for microemulsion and steroids according to medical judgement, opposite to the usual therapy which the patient already has received (typically: ciclosporin + azathioprine or mycophenolate mofetil + steroids according to the judgement of the doctor) for patients receiving a cardiac orthotopic transplant since at least 12 months. The patients will be randomized in a 2:1 proportion (everolimus:control), in order to make it possible for the majority of patients to receive the potentially active treatment in a lethal illness for which there is not efficient known treatment up to date.
The study duration will be 2 years of follow-up for each patient. At the end of this period, the patients will be offered the possibility to maintain the immunosuppressive treatment to which they have been assigned, and periodic revisions will be made each 3-6 months.
The two treatment groups are:
Group I - Everolimus twice a day v.o. + cyclosporin for microemulsion in reduced doses +/- steroids.
Group II - Cyclosporin for microemulsion + azathioprine or mycophenolate mofetil +/- steroids (the same administration schedule and medication which the patient received earlier).
This is the only study on the registry with Fundacion Investigacion y Desarrollo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Everolimus 2 times per day + cyclosporin low dose +/- steroids
Drug: everolimus
Cyclosporin + azathioprine or mofetil mycophenolate +/- steroids (the same treatment that patient had before the study).
Drug: azathioprine or mycophenolate mofetil
Everolimus 2 times per day, v.o., 2 years treatment.
Also known as: Certican
2 times per day during 2 years
Also known as: Imurel, Cellcept
Percentage of subjects that present at least one major clinical event due to graft vascular illness during the first year of the study on both treatment arms.
Time frame: December 2010
Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis.
Time frame: December 2010
This study is status unknown, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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