Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients

NCT05708508 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Rouen

Phase

Phase 3

Started

2024-03-28

Last updated

2026-02-17

Condition(s) studied

Kidney Transplant Infection

Investigational drug(s) / intervention(s)

ROVALCYTE

ROVALCYTE: "Immuno-guided strategy" arm

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

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. — 6 months
Proportion of patients with CMV infection within 6 months of transplantation.

Trial sites (1)

Facility	City	Region	Status
Chu Rouen	Rouen	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05708508 on ClinicalTrials.gov ↗ ← All trials in France