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 Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A (EVERCMV)

This is an interventional treatment trial for Transplantation Infection focused on measuring Cytomegalovirus infection and disease, CMV-seropositive recipients, Everolimus, preemptive strategy, mTOR inhibitor Read More

Inclusion Criteria:

• Age ≥ 18 years.
• End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation.
• Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor.
• Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type.
• Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study and two months later the discontinuation of the test drug.
• Total ischemia time below 36 hours.
• Capable of understanding the purpose and risks of the study.
• Fully informed and having given written informed consent (signed Informed Consent has been obtained).
• Affiliation to the social security regimen

Exclusion Criteria:

• CMV seronegative patient.
• Historical or current TGI (French equivalence of calculated PRA) > 85 %
• Presence of historical or current anti-HLA donor specific antibodies
• Patient who received anti-CMV therapy within the past 30 days prior to screening.
• Receiving or having previously received an organ transplant other than a kidney.
• Receiving a graft from a non-heart-beating donor.
• Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV; HBs Ag positive) or Hepatitis C (HCV; anti-HCV Ab positive).elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or receiving a graft from a hepatitis C or B positive donor.
• Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
• Known allergy or intolerance to everolimus, valganciclovir, ganciclovir, mycophenolic acid, basiliximab, corticosteroids, or cyclosporine A or any of the product excipients.
• Severe hyperlipidemia defined by: total cholestérol ≥ 9,1 mmol/L (≥ 350 mg/dL) et/ou triglycérides ≥ 8,5 mmol/l (≥ 750 mg/dL) in spite an adequate medication.

• Patient has adequate hematological post-transplant defined as:

  1. Absolute neutrophil count (ANC) > 1000 cells/μL.
  2. Platelet count > 50,000 cells/μL.
  3. Hemoglobin > 8.0 g/dL.
• Requiring initial therapy with induction immunosuppressive antibody preparations, such as anti-thymocyte globulins or rituximab or IVIG.
• Currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criteria
• Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
• Unlikely to comply with the visits scheduled in the protocol.