Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 5, 2024

Primary Completion Date

March 31, 2025

Study Completion Date

May 31, 2025

Conditions
CMV Infection
Interventions
DRUG

Letermovir 480 MG

Oral Letermovir for 84 days is effective in the prophylaxis of CMV infection in high-risk kidney transplant recipients. Oral Letermovir for 84 days, is associated with a lower incidence of CMV infection in high-risk high-risk kidney transplant recipients. In addition, the use of Letermovir is safe and associated with a low incidence of CMV syndrome or disease up to 6 months after after kidney transplantation. Finally, prophylaxis with Letermovir is associated with a lower incidence of discontinuation of immunosuppressive drugs, reducing the risk of of clinical and subclinical acute rejection

DRUG

Ganciclovir

The threshold for starting treatment with Ganciclovir is a CMV DNAemia \> 5,000 IU in a single measurement (CMV infection) measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (syndrome or disease).

All Listed Sponsors
lead

Hospital do Rim e Hipertensão

OTHER