Study of Prophylactic Vs Preemptive Valganciclovir | NCT00374686

Studies
Study of Prophylactic Vs Preemptive Valganciclovir

NCT00374686

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Sep 11, 2006Estimated

Enrollment

120

Phase

Not Applicable

Conditions

Cytomegalovirus Infection

Interventions

Valganciclovir

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Sep 7, 2006

First Submission Date that Met QC Criteria

Sep 7, 2006

First Posted Date

Sep 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2006

Last Update Posted Date

Sep 11, 2006Estimated

Name	Class
Hoffmann-La Roche	INDUSTRY

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Valganciclovir	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcomes included occurrence of CMV infection and disease and response to therapy

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel C Brennan, MD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16780548	Result	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. doi: 10.1111/j.1600-6143.2006.01413.x. Epub 2006 Jun 19.
39807668

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Term
D015774	Ganciclovir
D000212	Acyclovir
D006147	Guanine
D007042	Hypoxanthines
D011688