Cytomegalovirus Infection Clinical Trial
Official title:
A Multicenter, Two Arms, Randomized, Open Label Clinical Phase IV Study Investigating the Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection Within the First 6 Months Post-transplantation When Treated With an Immunosuppressive Regimen Including Everolimus (Certican®) and Reduced Dose of Cyclosporine A (Neoral®) Versus an Immunosuppressive Regimen With Mycophenolic Acid (Myfortic®) and Standard Dose of Cyclosporine A (Neoral®).
Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after transplantation. It is associated with an increased incidence of acute rejection and lower graft and patient survivals. The goal of this study is to demonstrate that an immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can prevent acute rejection episodes as efficiently as standard regimen but also efficiently reduce the incidence of CMV infection at 6 months post-transplantation.
Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after
kidney transplantation. Therefore most of the patients receive an universal prophylaxis. On
the contrary to CMV naïve patients, seropositive recipients (R+) have already mounted a
specific immunologic response directed against the virus, which is not completely abrogated
by immunosuppressive drugs. Although CMV infection management guidelines offer little
guidance on immunosuppressive therapy for preventing CMV infection and disease, recent data
plead for reappraising the place of mTOR inhibitors in this situation. The potential anti-CMV
action of these molecules could be added to their potential antitumor effect and their
equivalent immunosuppressive efficacy in kidney transplant recipients at low immunological
risk. By the way, it could represent an alternative of a systematic universal prophylaxis in
R+ kidney transplant recipients. However, the proof of this anti-CMV action must be confirmed
in vivo in a study, which could have a close monitoring of CMV infection.
We therefore designed a prospective multicentric randomized controlled trial comparing an
immunosuppressive regimen based on everolimus and reduced dose of cyclosporine A to a regimen
based on mycophenolic acid and standard dose of cyclosporine A, in order to demonstrate the
superiority of the first one in the prevention of CMV infection.
Subjects will be randomized to one of the two treatment arms and will be followed for a
period of 12 months. Whole blood CMV real time PCR will be performed every week during the
first three months, then every two weeks from Month 3 to Month 6, then at Months 8, 10 and
12. Incidence of CMV infection will be compared between the two arms at 6 and 12 months
post-transplantation.
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