Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374686
Status:
COMPLETED
Last Update Posted:
2006-09-11
First Post:
2006-09-07
Brief Title:
Study of Prophylactic Vs Preemptive Valganciclovir
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Prophylactic Vs Preemptive Oral Valganciclovir for Management of Cytomegalovirus Infection in Adult Renal Transplant Recipients A Clinical and Pharmacoeconomic Study
Status:
COMPLETED
Status Verified Date:
2005-09
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:
This is a study of prophylactic Vs preemptive oral valganciclovir for management of cytomegalovirus infection in adult renal transplant recipients looking at clinical and pharmacoeconomic outcomes
Detailed Description:
This is a study of prophylactic Vs preemptive oral valganciclovir for management of cytomegalovirus infection in adult renal transplant recipients looking at clinical and pharmacoeconomic outcomes Patients at risk for CMV DR- DR D-R were randomized to prophylaxis valganciclovir 900 mg qd for 100 days n49 or preemptive therapy 900 mg bid for 21 days n49 for CMV DNAemia CMV DNA level 2000 copiesml in 1 whole blood specimens by quantitative PCR done weekly for 16 weeks then at months 5 6 9 and 12 Clinical and virologic outcomes were measured and pharmacoeconomic outcomes will be analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None