A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 5, 2006

Last Updated Date

May 13, 2009

Start Date ^†

May 2006

Current Primary Outcome Measures ^†

Percentage of patients with active CMV infection, or CMV disease. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Urine proteomic pattern [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Time to graft loss [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

% of patients with active CMV infection within 12 months; % with CMV disease within 12 months; urine proteomic pattern at month 12; time to graft loss

Change History

Complete list of historical versions of study NCT00372229 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

CMV syndrome or tissue invasive disease; viremia; acute rejection; creatinine clearance; leucopenia and neutropenia; opportunistic infections; graft and patient survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation

Official Title ^†

A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-Emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration

Brief Summary

This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Cytomegalovirus Infections

Intervention ^†

Drug: valganciclovir [Valcyte]
Drug: Pre-emptive therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

300

Estimated Completion Date

December 2015

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

primary or secondary renal allograft within preceding 14 days;
IgG seropositive for CMV;
receiving immunosuppressive therapy.

Exclusion Criteria:

active CMV infection;
current/history of malignancy;
acute steroid resistant rejection episode since transplantation.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Austria, Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00372229

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Secondary IDs ^††

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.