Patients receiving a kidney transplant (1 to 12 days post-transplant)
Conditions
Interventions
Trade Name: ROVALCYTE 450 mg, ROCHE
Product Name: valganciclovir
Product Code: ROVALCYTE 450 mg, comprimé pelliculé
Pharmaceutical Form: Capsule
Sponsors
DRCI - CHU de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: • Age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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;Primary end point(s): Proportion of patients with CMV infection within 6 months of transplantation.;Timepoint(s) of evaluation of this end point: 6-months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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;Timepoint(s) of evaluation of this end point: 3, 6 and 12-months | — |
Countries
France
Contacts
Public ContactDavid MALLET
DRCI - CHU de Rouen
Outcome results
None listed