A Phase 3 interventional study of ROVALCYTE in Kidney Transplant Infection, sponsored by University Hospital, Rouen. Recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by University Hospital, Rouen · Phase 3, Interventional, and Prevention
Cytomegalovirus (CMV) establishes a chronic infection in 60% of the general population. In renal transplant recipients, it is responsible for morbidities occurring mainly in the first 6 months after transplantation. These include viral reactivations linked to immunosuppressive treatment inhibiting the anti-CMV T lymphocyte response. CMV infection, a sign of uncontrolled viral replication, is defined by the detection of viral DNA in the peripheral blood (DNAemia). CMV disease is defined as the association of an infection and symptoms attributable to the virus.
In transplant recipients carrying the virus before transplantation (positive serology: CMV+), two infection prevention strategies are recommended: either close monitoring of DNAemia with antiviral treatment in the event of positive detection (pre-emptive strategy), or antiviral treatment for the first 3 months following the transplant (prophylactic strategy). Both strategies result in the occurrence of CMV infection in 15 to 20% of patients within the first 6 months, with the majority of events occurring between 3 and 6 months.
Numerous studies show that the evaluation of the anti-CMV T lymphocyte response, either before (D0) or early after transplantation (D15), or when antiviral prophylaxis is stopped, allows the identification of patients at risk of CMV infection. No study has yet demonstrated the contribution of such an evaluation in a preventive strategy.
University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to the immuno-guided strategy arm will receive a cytomegalovirus (CMV) prevention strategy based on anti-CMV immune response assessment at Day 15 post-transplant. * Participants classified as low risk will not receive systematic antiviral prophylaxis and will undergo preemptive monitoring for CMV infection from Day 15 to Week 28 post-transplant. * Participants classified as high risk (anti-CMV immune response \<130 SFC/10⁶ cells) will receive antiviral prophylaxis with valganciclovir starting at Day 15 post-transplant. At Week 15, antiviral treatment will be discontinued in participants reclassified as low risk. Participants remaining classified as high risk will continue antiviral treatment until Week 28 post-transplant.
Drug: ROVALCYTE
Participants randomized to the universal prophylaxis arm will receive antiviral prophylaxis with valganciclovir starting at Day 15 post-transplant and continuing for 3 months following transplantation. Participants will undergo standard clinical and biological monitoring, including CMV DNAemia surveillance, for up to 6 months post-transplant according to routine practice at the participating centers.
Drug: ROVALCYTE
"Immuno-guided strategy" arm
Demonstrate, in CMV+ transplant patients, the efficacy of an immuno-guided preventive strategy compared to the universal prophylactic strategy, in terms of CMV infection in the 6 months following kidney transplantation.
Proportion of patients with CMV infection within 6 months of transplantation.
Time frame: 6 months
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University Hospital, Rouen