Trial information
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 type: Interventional; Prevention; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
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:
- 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: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2006
Trial registration date: 03/16/2006
Date last updated: 12/2/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
Germany
- Aachen
- Berlin
- Bremen
- Düsseldorf
- Erlangen
- Essen
- Frankfurt Am Main
- Hamburg
- Hann. Münden
- Hannover
- Jena
- Koeln
- Leipzig
- Lübeck
- München
- Münster
- Regensburg
- Tübingen
- Würzburg
