Study of Prophylactic Vs Preemptive Valganciclovir

Cytomegalovirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374686
• Other study ID #: VAL015 HSC02-0140
• Status: Completed
• Phase: N/A
• First received: September 7, 2006
• Last updated: September 7, 2006
• Start date: March 2003
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cytomegalovirus Infection
• Cytomegalovirus Infections

Intervention

Drug:
• Valganciclovir

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcomes included occurrence of CMV infection and disease and response to therapy
Secondary	Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia