Trial Information

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

Status: Recruiting

Protocol Number: ML19313

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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. Target sample size is 300.

Study Phase: III

Study Design / Study Details:

• Purpose: Prevention
• Allocation:
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Cytomegalovirus infections

Intervention Type: Drug

Intervention Name: valganciclovir [Valcyte]

Primary Outcome: 1. Percentage of patients with active CMV infection, or CMV disease. Time frame: 12 months 2. Urine proteomic pattern Time frame: 12 months 3. Time to graft loss Time frame: Event driven

Key Secondary Outcomes: 1. CMV syndrome or tissue invasive disease; viremia; acute rejection; creatinine clearance; leucopenia and neutropenia; opportunistic infections; graft and patient survival. Time frame: 12 months

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2006

Trial Registration Date: 03/16/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:59:52 PM