Last updated on October 2018

Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporineversus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02328963

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Lionel COUZI, MD

CHU de Bordeaux
Bordeaux, France

Yannick Lemeur, MD, PhD

CHU La Cavale Blanche
Brest, France

Nicolas BOUVIER, MD

CHRU Caen - H pital de Caen
Caen, France

Marc HAZZAN, MD, PhD

CHRU de Lille - H pital Huriez
Lille, France

Marie ESSIG, MD

CHU de Limoges - H pital Dupuytren
Limoges, France

Emmanuel Morelon, MD, PhD

H pital Edouard Herriot
Lyon, France

Christophe Legendre, MD, PhD

APHP - H pital Necker
Paris, France

Antoine Durrbach, MD, PhD

APHP - Kremlin Bicetre
Paris, France

Bruno Moulin, Pr

CHRU Strasbourg
Strasbourg, France

Lionel Rostaing, Md, PhD

CHU de Toulouse - H pital Rangueil
Toulouse, France