Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06001320
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-07-18
Brief Title:
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Trans Recip
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Historical Controlled Single Center Open Label Pilot Comparing the Effectiveness and Tolerability of De-novo Initiation of Letermovir Versus Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
Status:
RECRUITING
Status Verified Date:
2023-10
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:
CMV viremia will be treated with either oral valganciclovir intravenous ganciclovir or alternative agents according to AST ID COP American Society of Transplantation Infectious disease community of practice guidelines
Detailed Description:
Intervention Letermovir prophylaxis Prophylaxis is once daily dose of Letermovier starting Day 1 of post-transplant up until 6 months post-transplant
Participants enrolled in this study will also receive prophylactic acyclovir 400mg twice daily for the duration of their Letermovir treatment
Strategy for CMV Viremia CMV viremia will be treated with either oral valganciclovir intravenous ganciclovir or alternative agents according to AST ID COP American Society of Transplantation Infectious disease community of practice guidelines
Participants enrolled in this study will also receive prophylactic acyclovir 400mg twice daily for the duration of their Letermovir treatment
Strategy for CMV Viremia CMV viremia will be treated with either oral valganciclovir intravenous ganciclovir or alternative agents according to AST ID COP American Society of Transplantation Infectious disease community of practice guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None