Immune-guided versus universal antiviral prevention for CMV after kidney transplant

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

We will test whether using immune-guided monitoring to decide who needs antiviral treatment works better than giving everyone three months of antiviral pills after a CMV-positive kidney transplant.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Drugs / interventions: Basiliximab
• Locations: 1 site (Rouen)
• Trial ID: NCT05708508 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial enrolls adults who are CMV seropositive and have received a kidney transplant within 1–12 days, with non‑depleting induction (basiliximab) and no detectable CMV DNAemia at baseline. Participants are assigned to an immune‑guided prevention strategy—using immune and/or DNAemia monitoring to trigger antiviral therapy—or to universal prophylaxis with valganciclovir (Rovalcyte) for the first three months post‑transplant. The study follows patients through the early high‑risk post‑transplant period to record CMV DNAemia, CMV disease, and safety outcomes including blood count abnormalities. The aim is to see if targeted antiviral use can prevent CMV disease while reducing unnecessary drug exposure and toxicity.

Who should consider this trial

Good fit: Adults who are CMV IgG positive on the day of transplantation, received basiliximab induction, and can be enrolled within 1–12 days after the transplant with no detectable CMV DNAemia are ideal candidates.

Not a fit: Patients with detectable CMV DNAemia at baseline, those who received lymphodepleting induction (antithymocyte globulin), or those with severe cytopenias are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could prevent CMV disease while reducing unnecessary antiviral exposure and drug-related side effects for kidney transplant patients.

How similar studies have performed: Universal prophylaxis and pre‑emptive DNAemia monitoring are established approaches, and smaller studies of immune‑guided strategies using CMV‑specific T‑cell tests have shown promise but large phase 3 confirmation is limited.

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

Where this trial is running

Rouen

• Chu Rouen — Rouen, France (Recruiting)

Study contacts

• Study coordinator: Dominique Bertrand

Conditions Kidney Transplant Infection