Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341686
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-07
Brief Title:
Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection
Sponsor:
Hospital do Rim e Hipertensão
Organization:
Hospital do Rim e Hipertensão
Study Overview
Official Title:
Efficacy and Safety of Prophylactic Use of Letermovir Versus Preemptive Strategy in Kidney Transplant Recipients at Higher Risk of Cytomegalovirus Infection a Prospective Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The two main cytomegalovirus CMV prevention strategies are prophylaxis and preemptive therapy Prophylaxis effectively prevents CMV infection after solid organ transplantation SOT but is associated with high rates of neutropenia and late onset of post-prophylactic disease In contrast preemptive therapy has the advantage of leading to lower rates of CMV disease and robust humoral and T-cell responses It is widely used in hematopoietic cell transplant recipients but is rarely used after solid organ transplant recipients due to logistical considerations
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None