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Completed

NCT Number: NCT00374686

Study of Prophylactic Vs Preemptive Valganciclovir

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

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Key information

Conditions

Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valganciclovir

Drug

Primary outcomes

  1. Primary outcomes included occurrence of CMV infection and disease and response to therapy

Secondary outcomes

  1. Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Prophylactic Vs Preemptive Oral Valganciclovir for Management of Cytomegalovirus Infection in Adult Renal Transplant Recipients: A Clinical and Pharmacoeconomic Study

Important dates

Study start
2003
Study completion
2005
First posted
Sep 11, 2006
Registry last updated
Sep 11, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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