Cytomegalovirus Infection
Conditions
Keywords
cytomegalovirus, kidney, transplantation, valganciclovir, preemptive
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
Interventions
DRUGValganciclovir
Sponsors
Hoffmann-La Roche
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes included occurrence of CMV infection and disease and response to therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia | — |
Countries
United States
Outcome results
None listed