ClinicalTrials.Veeva

Menu

Study of Prophylactic Vs Preemptive Valganciclovir

The Washington University logo

The Washington University

Status

Completed

Conditions

Cytomegalovirus Infection

Treatments

Drug: Valganciclovir

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00374686
VAL015 HSC02-0140

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems