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

Launched by UNIVERSITY HOSPITAL, ROUEN · Jan 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different strategies to help prevent a common infection called Cytomegalovirus (CMV) in kidney transplant patients. CMV can cause serious health problems, especially in the first six months after a transplant. The trial aims to find out if a new approach that monitors the body’s immune response to CMV can effectively reduce the risk of infection compared to the standard method of giving medication for three months after the transplant.

To participate in the trial, you need to be a kidney transplant patient who is between 18 and 80 years old and has tested positive for CMV before the transplant. You should not have any active CMV infection or certain blood conditions. If you join, you can expect close monitoring and care during the study period. This trial is an important step in understanding how to best protect kidney transplant patients from CMV infections, potentially leading to better health outcomes.

Gender

ALL

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