Study of Prophylactic Vs Preemptive Valganciclovir

ID: NCT00374686
Status: Completed
Phase: N/A
Start Date: March 01, 2003
First Submitted: September 07, 2006
Last Updated: September 07, 2006
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine, Hoffmann-La Roche
Location: United States
Conditions: Cytomegalovirus Infection
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Study Description

Brief 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

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
Condition or disease Intervention/treatment Phase

Cytomegalovirus Infection

Drug: Valganciclovir
Other Names
N/A

Tracking Information

First Submitted DateSeptember 07, 2006
Last Update Posted DateSeptember 07, 2006
Start DateMarch 01, 2003
Completion DateSeptember 01, 2005
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

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

Original Secondary Outcome Measures

Not Available

Study Design

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

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

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
120
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None
Primary Purpose
Prevention
Conditions
Cytomegalovirus Infection
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Valganciclovir

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment120
Completion DateSeptember 01, 2005
Eligibility 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
GenderAll
Age18 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00374686
Other Study ID Numbers
VAL015 HSC02-0140
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyN/A
Study Sponsor
Washington University School of Medicine
Collaborators
Hoffmann-La Roche
Investigators
Principal Investigator
Daniel C Brennan, MD
Washington University School of Medicine