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    Summary
    EudraCT Number:2022-002556-39
    Sponsor's Protocol Code Number:2020/0422/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-11-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2022-002556-39
    A.3Full title of the trial
    Efficacy of a preventive strategy for immuno-guided cytomegalovirus infection compared to a universal prophylactic strategy in renal transplant recipients
    Efficacité d’une stratégie préventive de l’infection à cytomégalovirus immuno-guidée comparativement à une stratégie prophylactique universelle chez le transplanté rénal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of a preventive strategy for immuno-guided cytomegalovirus infection compared to a universal prophylactic strategy in renal transplant recipients
    A.3.2Name or abbreviated title of the trial where available
    CYTOPREV
    A.4.1Sponsor's protocol code number2020/0422/HP
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDRCI - CHU de Rouen
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDRCI - CHU de Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRCI - CHU de Rouen
    B.5.2Functional name of contact pointDavid MALLET
    B.5.3 Address:
    B.5.3.1Street Address1 rue de germont
    B.5.3.2Town/ cityRouen Cedex
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number330232888265
    B.5.5Fax number330232888287
    B.5.6E-mailsecretariat.drc@chu-rouen.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ROVALCYTE 450 mg, ROCHE
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namevalganciclovir
    D.3.2Product code ROVALCYTE 450 mg, comprimé pelliculé
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients receiving a kidney transplant (1 to 12 days post-transplant)
    E.1.1.1Medical condition in easily understood language
    Patients receiving a kidney transplant (1 to 12 days post-transplant)
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate, in CMV+ transplant patients, the effectiveness of an immuno-guided preventive strategy compared to the universal prophylactic strategy, in terms of CMV infection in the 6 months following kidney transplantation.
    E.2.2Secondary objectives of the trial
    1. Demonstrate the effectiveness of an immuno-guided preventive strategy compared to the universal prophylactic strategy, in terms of
    - recourse to a curative treatment for the CMV infection, within 6 months
    - the occurrence of CMV disease within 6 months of the transplant.
    - preventing CMV infection at 1 year post-transplantation.
    2. Compare the T lymphocyte response at W+15 post-transplantation in low- and high-risk patients in the experienced group.
    3. Compare the T lymphocyte response at W+28 post-transplant in low- and high-risk patients in the experienced group.
    4. Compare the incidence of CMV reactivations according to the serological status of the donor (D+/R+ versus D-/R+) in the experienced group and the comparator group.
    5. Cost-effectiveness analysis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18 years ≤ Age ≤ 75 years
    • Renal transplant patient for 1 to 12 days
    • CMV seropositivity on the day of transplantation: IgG threshold =6 AU/mL CMIA CMV IgG, Architect i4000 (Abbott)) (Serology performed on D0, before the transplant)
    • Non-depleting inducing immunosuppressive treatment (Basiliximab) (implementation before the transplant)
    • Affiliation to a social security scheme
    • Patient having read and understood the information letter and signed the consent form
    E.4Principal exclusion criteria
    • Age < 18 or > 75
    • Active CMV infection (detectable CMV DNAemia - peripheral CMV DNAemia ≥ 305 IU/mL)
    • Patient with hypersensitivity to valganciclovir, ganciclovir, aciclovir or valaciclovir or to any of the excipients
    • Lympho-depleting inducing immunosuppressive treatment (antithymoglobulins)
    • Neutropenia (neutrophils < 500/mm3) or thrombocytopenia (platelets < 25,000/mm3) or anemia (hemoglobin < 8G/L) identified on routine care samples taken on the day of inclusion
    • Pregnant or parturient or breast-feeding woman or absence of proven contraception
    • Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
    • History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for their participation in the protocol or preventing them from giving their informed consent
    • Person participating in another interventional trial.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with CMV infection within 6 months of transplantation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6-months
    E.5.2Secondary end point(s)
    1. Proportion of patients requiring the use of curative antiviral treatment within 6 months after transplantation
    2. Proportion of patients with CMV disease within 6 months of transplantation
    3. Proportion of patients with CMV infection (CMV DNAemia ≥ 305 IU/mL (= 2.3 log IU/mL), CMV infection (CMV DNAemia ≥ 4 log IU/mL requiring curative treatment or CMV disease within the first year following transplant
    4. Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+15
    5. Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+28
    6. CMV serological status of the donor (D+/R+ versus D-/R+)
    7. Incremental cost-effectiveness ratio per COGS avoided
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 and 12-months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Preventive strategy for immune-guided cytomegalovirus infection
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial a is the last collect in from the medical file of the last enrolled patient into the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state144
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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