NCT05708508 Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients
| NCT ID | NCT05708508 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Rouen |
| Condition | Kidney Transplant Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-03-28 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 144 participants in total. It began in 2024-03-28 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05708508 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Kidney Transplant Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05708508 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 144 participants.
Is NCT05708508 currently recruiting?
Yes, NCT05708508 is actively recruiting participants. Contact the research team at dominique.bertrand@chu-rouen.fr for enrollment information.
Where is the NCT05708508 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT05708508 clinical trial?
NCT05708508 is sponsored by University Hospital, Rouen. The trial plans to enroll 144 participants.
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