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Study of Prophylactic Vs Preemptive Valganciclovir

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00374686
First received: September 7, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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


Condition Intervention
Cytomegalovirus Infection
 Drug: Valganciclovir

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylactic Vs Preemptive Oral Valganciclovir for Management of Cytomegalovirus Infection in Adult Renal Transplant Recipients: A Clinical and Pharmacoeconomic Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

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

Estimated Enrollment: 120
Study Start Date: March 2003
Estimated Study Completion Date: September 2005
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374686

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Hoffmann-La Roche
Investigators
Principal Investigator: Daniel C Brennan, MD Washington University School of Medicine
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00374686     History of Changes
Other Study ID Numbers: VAL015 HSC02-0140
Study First Received: September 7, 2006
Last Updated: September 7, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
cytomegalovirus
kidney
transplantation
valganciclovir
preemptive

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
 Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013