Study of Prophylactic Vs Preemptive Valganciclovir
- Conditions
- Cytomegalovirus Infection
- Registration Number
- NCT00374686
- Lead Sponsor
- Washington University School of Medicine
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- All patients who received a kidney transplant at Washington University Medical Center between March 2003 and June 2004.
- Age younger than 18
- Refusal to consent for the study
- Allergy to ganciclovir and severe illness too serious to justify randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary outcomes included occurrence of CMV infection and disease and response to therapy
- Secondary Outcome Measures
Name Time Method Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States