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

NCT05708508 | Recruiting Phase 3

• 1 other identifier: 2020/0422/HP
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

"Immuno-guided strategy" arm

EXPERIMENTAL

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

"Universal prophylaxis" arm

ACTIVE COMPARATOR

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

Interventions

ROVALCYTE DRUG

"Immuno-guided strategy" arm

"Immuno-guided strategy" arm; "Universal prophylaxis" arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Chu Rouen

Rouen, 76031, France

RECRUITING

Related Publications (1)

• Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.

  PMID: 39807668 DERIVED

Central Study Contacts

Dominique Bertrand

CONTACT

0232885452; dominique.bertrand@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: March 28, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)