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 (Néoral®) versus an immunosuppressive regimen with mycophenolic acid (Myfortic®) and standard dose of cyclosporine A (Néoral®). - EVERCMV

• Conditions: CMV infection in CMV-seropositive de novo kidney transplant recipients receiving an immunosuppressive regimen.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-003195-12-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-16
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1)Age = 18 years
2)End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation
3)Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor
4)Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type
5)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
6)Total ischemia time below 36 hours
7)Capable of understanding the purpose and risks of the study
8)Fully informed and having given written informed consent (signed Informed Consent has been obtained)
9)Affiliation to the social security regimen
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)CMV seronegative patient
2)Historical or current TGI (French equivalence of calculated PRA) > 85 %
3)Presence of historical or current anti-HLA donor specific antibodies
4)Patient who received anti-CMV therapy within the past 30 days prior to screening
5)Receiving or having previously received an organ transplant other than a kidney
6)Receiving a graft from a non-heart-beating donor
7)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
8)Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
9)Known allergy or intolerance to everolimus, valganciclovir, ganciclovir, mycophenolic acid, basiliximab, corticosteroids, or cyclosporine A or any of the product excipients
10)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
11)Patient has adequate hematological post-transplant defined as:
a) Absolute neutrophil count (ANC) > 1000 cells/µL
b) Platelet count > 50,000 cells/µL
c) Hemoglobin > 8.0 g/dL
12)Requiring initial therapy with induction immunosuppressive antibody preparations, such as anti-thymocyte globulins or rituximab or IVIG
13)Currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criteria
14)Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
15)Unlikely to comply with the visits scheduled in the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified