Valganciclovir for Cytomegalovirus infection

Inclusion criteria

• {"criterion_text":"- 18 years ≤ Age ≤ 75 years"}
• {"criterion_text":"- Renal transplant patient for 1 to 12 days"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Non-depleting inducing immunosuppressive treatment (Basiliximab) (implementation before the transplant)"}
• {"criterion_text":"- Affiliation to a social security scheme"}
• {"criterion_text":"- Patient having read and understood the information letter and signed"}
• {"criterion_text":"- For women: - Woman of childbearing potential using effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) for at least 1 month and a negative β-HCG blood pregnancy test at inclusion, throughout the duration of study treatment and for at least 30 days after stopping study treatment. - Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months before the inclusion visit) - Surgically sterile woman (absence of ovary and/or uterus)"}
• {"criterion_text":"- Pour les hommes : - Stérilité chirurgicale, ou - Contraception mécanique (préservatif) pendant toute la durée du traitement à l’étude et pendant au moins 90 jours après la fin du traitement à l’étude, ou - Avec une partenaire en âge de procréer prenant une contraception efficace (Cf. CTFG) (oestro-progestatifs ou dispositif intra-utérin ou ligature de trompes) depuis au moins 1 mois à l’inclusion, pendant toute la durée du traitement à l’étude et pendant au moins 90 jours après l’arrêt du traitement, ou - Avec une partenaire ménopausée : diagnostic de confirmation (aménorrhée non médicalement induite depuis au moins 12 mois avant la visite d’inclusion), ou - Avec une partenaire chirurgicalement stérile (absence d’ovaire et/ou d’utérus)."}

Exclusion criteria

• {"criterion_text":"- Age < 18 or > 75"}
• {"criterion_text":"- Active CMV infection (detectable CMV DNAemia - peripheral CMV DNAemia ≥ 305 IU/mL)"}
• {"criterion_text":"- Patient with hypersensitivity to valganciclovir, ganciclovir, aciclovir or valaciclovir or to any of the excipients"}
• {"criterion_text":"- Lympho-depleting inducing immunosuppressive treatment (antithymoglobulins)"}
• {"criterion_text":"- Neutropenia (neutrophils < 500/mm3) or thrombocytopenia (platelets < 25,000/mm3) or anemia (hemoglobin < 8g/dl) identified on routine care samples taken on the day of inclusion"}
• {"criterion_text":"- Pregnant or parturient or breast-feeding woman or absence of proven contraception"}
• {"criterion_text":"- Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Person participating in another interventional trial (Medicinal product)"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with CMV infection within 6 months of transplantation.","definition_or_measurement_approach":"Proportion of patients with CMV infection within 6 months of transplantation. CMV infection is defined in the record (see secondary endpoints) with CMV DNAemia thresholds (CMV DNAemia ≥ 305 IU/mL referenced in endpoints)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients requiring the use of curative antiviral treatment within 6 months after transplantation","definition_or_measurement_approach":"Proportion of patients requiring curative antiviral treatment within 6 months post-transplant (as recorded)."}
• {"endpoint_text":"- Proportion of patients with CMV disease within 6 months of transplantation","definition_or_measurement_approach":"Proportion of patients meeting criteria for CMV disease within 6 months post-transplant (as recorded)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"CMV infection defined by CMV DNAemia ≥ 305 IU/mL (=2.3 log IU/mL); clinically significant infection defined as CMV DNAemia ≥ 4 log IU/mL requiring curative treatment or CMV disease within first year post-transplant."}
• {"endpoint_text":"- Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+15","definition_or_measurement_approach":"Quantitative measurement of CMV-specific T lymphocytes (IE-1 and pp65) at week +15 post-transplant."}
• {"endpoint_text":"- Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+28","definition_or_measurement_approach":"Quantitative measurement of CMV-specific T lymphocytes (IE-1 and pp65) at week +28 post-transplant."}
• {"endpoint_text":"- CMV serological status of the donor (D+/R+ versus D-/R+)","definition_or_measurement_approach":"Donor/recipient CMV serostatus comparison (D+/R+ vs D-/R+)."}
• {"endpoint_text":"- Incremental cost-effectiveness ratio will be calculated for the period from randomization to the visit at S+28 post-transplantation for the experimental group (Arm ) compared to the comparator group (Arm ) with the average costs and efficacies for each strategy. The incremental cost-effectiveness ratio will be presented as additional cost per CMV infection avoided.","definition_or_measurement_approach":"Economic evaluation: incremental cost-effectiveness ratio from randomization to S+28 post-transplantation comparing the two strategies; presented as additional cost per CMV infection avoided."}

France

Earliest CTIS Part Ii Submission Date

07-08-2024

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

596

Number Of Sites

2

Number Of Participants

144

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France