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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

September 7, 2006
September 7, 2006
March 2003
Not Provided
Primary outcomes included occurrence of CMV infection and disease and response to therapy
Same as current
No Changes Posted
Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia
Same as current
Not Provided
Not Provided
 
Study of Prophylactic Vs Preemptive Valganciclovir
Prophylactic Vs Preemptive Oral Valganciclovir for Management of Cytomegalovirus Infection in Adult Renal Transplant Recipients: A Clinical and Pharmacoeconomic 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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cytomegalovirus Infection
Drug: Valganciclovir
Not Provided
Khoury JA, Storch GA, Bohl DL, Schuessler RM, Torrence SM, Lockwood M, Gaudreault-Keener M, Koch MJ, Miller BW, Hardinger KL, Schnitzler MA, Brennan DC. Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. Am J Transplant. 2006 Sep;6(9):2134-43. Epub 2006 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
September 2005
Not Provided

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374686
VAL015 HSC02-0140
Not Provided
Not Provided
Washington University School of Medicine
Hoffmann-La Roche
Principal Investigator: Daniel C Brennan, MD Washington University School of Medicine
Washington University School of Medicine
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP