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

RecruitingPhase 3Ages 18 Years - 75 YearsAllUniversity Hospital, Rouen
NCT05708508 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 transpl

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📋 Eligibility rules (as published)
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
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What it tests

  • ROVALCYTE
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Where

1 site
Chu Rouen
Rouen, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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