search
Back to results

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

Primary Purpose

Kidney Transplant Infection

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ROVALCYTE
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Transplant Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    "Immuno-guided strategy" arm

    "Universal prophylaxis" arm

    Arm Description

    Patients in the "low risk" group will be monitored between D+15 and W+28 according to a strategy preemptive. Patients in the "high risk" group (anti-CMV response <130 SFC/106 cells) will be treated according to the terms of the "universal prophylaxis" arm from D+15 and until W+15. At the W+15 visit: If the patient is considered at "low risk", the antiviral treatment is stopped and he will continue the follow-up according to the modalities of the "universal prophylaxis" arm until W+28. If the patient is still at "high risk" antiviral treatment will be continued until W+28.

    Patients will receive from D+15 post-transplant an antiviral treatment with valganciclovir (ROVALCYTE) for the first 3 months following the transplant. Clinico-biological monitoring during the 6 months according to the usual practices of the 2 centers and monitoring of CMV DNAemia.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2023
    Last Updated
    January 23, 2023
    Sponsor
    University Hospital, Rouen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05708508
    Brief Title
    Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients
    Acronym
    CYTOPREV
    Official Title
    Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 31, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2026 (Anticipated)
    Study Completion Date
    June 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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. We therefore propose such a study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Transplant Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    144 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    "Immuno-guided strategy" arm
    Arm Type
    Experimental
    Arm Description
    Patients in the "low risk" group will be monitored between D+15 and W+28 according to a strategy preemptive. Patients in the "high risk" group (anti-CMV response <130 SFC/106 cells) will be treated according to the terms of the "universal prophylaxis" arm from D+15 and until W+15. At the W+15 visit: If the patient is considered at "low risk", the antiviral treatment is stopped and he will continue the follow-up according to the modalities of the "universal prophylaxis" arm until W+28. If the patient is still at "high risk" antiviral treatment will be continued until W+28.
    Arm Title
    "Universal prophylaxis" arm
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive from D+15 post-transplant an antiviral treatment with valganciclovir (ROVALCYTE) for the first 3 months following the transplant. Clinico-biological monitoring during the 6 months according to the usual practices of the 2 centers and monitoring of CMV DNAemia.
    Intervention Type
    Drug
    Intervention Name(s)
    ROVALCYTE
    Intervention Description
    "Immuno-guided strategy" arm
    Primary Outcome Measure Information:
    Title
    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.
    Description
    Proportion of patients with CMV infection within 6 months of transplantation.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique Bertrand
    Phone
    0232885452
    Email
    dominique.bertrand@chu-rouen.fr

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs