Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients (CYTOPREV)
Kidney Transplant Infection
About this trial
This is an interventional prevention trial for Kidney Transplant Infection
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
"Immuno-guided strategy" arm
"Universal prophylaxis" arm
Patients in the "low risk" group will be monitored between D+15 and W+28 according to a strategy preemptive. Patients in the "high risk" group (anti-CMV response <130 SFC/106 cells) will be treated according to the terms of the "universal prophylaxis" arm from D+15 and until W+15. At the W+15 visit: If the patient is considered at "low risk", the antiviral treatment is stopped and he will continue the follow-up according to the modalities of the "universal prophylaxis" arm until W+28. If the patient is still at "high risk" antiviral treatment will be continued until W+28.
Patients will receive from D+15 post-transplant an antiviral treatment with valganciclovir (ROVALCYTE) for the first 3 months following the transplant. Clinico-biological monitoring during the 6 months according to the usual practices of the 2 centers and monitoring of CMV DNAemia.