Back to resultsStudy of Prophylactic Vs Preemptive Valganciclovir
Primary Purpose
Cytomegalovirus Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Valganciclovir
Sponsored by
About this trial
This is an interventional prevention trial for Cytomegalovirus Infection focused on measuring cytomegalovirus, kidney, transplantation, valganciclovir, preemptive
Eligibility Criteria
Inclusion Criteria:
- All patients who received a kidney transplant at Washington University Medical Center between March 2003 and June 2004.
Exclusion Criteria:
- Age younger than 18
- Refusal to consent for the study
- Allergy to ganciclovir and severe illness too serious to justify randomization
Sites / Locations
- Washington University School of Medicine
Outcomes
Primary Outcome Measures
Primary outcomes included occurrence of CMV infection and disease and response to therapy
Secondary Outcome Measures
Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia
Full Information
NCT ID
NCT00374686
First Posted
September 7, 2006
Last Updated
September 7, 2006
Sponsor
Washington University School of Medicine
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00374686
Brief Title
Study of Prophylactic Vs Preemptive Valganciclovir
Official Title
Prophylactic Vs Preemptive Oral Valganciclovir for Management of Cytomegalovirus Infection in Adult Renal Transplant Recipients: A Clinical and Pharmacoeconomic Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Washington University School of Medicine
Collaborators
Hoffmann-La Roche
4. Oversight
5. Study Description
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 (D+/R-, D+/R+, D-/R+) were randomized to prophylaxis (valganciclovir 900 mg qd for 100 days, n=49) or preemptive therapy (900 mg bid for 21 days, n=49) for CMV DNAemia (CMV DNA level >2000 copies/ml 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infection
Keywords
cytomegalovirus, kidney, transplantation, valganciclovir, preemptive
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Primary Outcome Measure Information:
Title
Primary outcomes included occurrence of CMV infection and disease and response to therapy
Secondary Outcome Measure Information:
Title
Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who received a kidney transplant at Washington University Medical Center between March 2003 and June 2004.
Exclusion Criteria:
Age younger than 18
Refusal to consent for the study
Allergy to ganciclovir and severe illness too serious to justify randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C Brennan, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16780548
Citation
Khoury JA, Storch GA, Bohl DL, Schuessler RM, Torrence SM, Lockwood M, Gaudreault-Keener M, Koch MJ, Miller BW, Hardinger KL, Schnitzler MA, Brennan DC. Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. Am J Transplant. 2006 Sep;6(9):2134-43. doi: 10.1111/j.1600-6143.2006.01413.x. Epub 2006 Jun 19.
Results Reference
result
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Study of Prophylactic Vs Preemptive Valganciclovir
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