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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00372229
First Posted: September 6, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Cytomegalovirus Infections Drug: Pre-emptive therapy Drug: valganciclovir [Valcyte] Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with active CMV infection, or CMV disease. [ Time Frame: 12 months ]
  • Urine proteomic pattern [ Time Frame: 12 months ]
  • Time to graft loss [ Time Frame: Event driven ]

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 ]

Enrollment: 301
Study Start Date: May 2006
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: valganciclovir [Valcyte]
900mg po for 100 days
Active Comparator: 2 Drug: Pre-emptive therapy
As prescribed

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372229


Locations
Austria
Innsbruck, Austria, 6020
Wien, Austria, 1090
Germany
Aachen, Germany, 52057
Berlin, Germany, 12203
Berlin, Germany, 13353
Bremen, Germany, 28205
Düsseldorf, Germany, 40225
Erlangen, Germany, 91054
Essen, Germany, 45122
Frankfurt, Germany, 60596
Freiburg, Germany, 79106
Hamburg, Germany, 20246
Hann. Münden, Germany, 34346
Hannover, Germany, 30625
Jena, Germany, 07747
Köln, Germany, 50937
Leipzig, Germany, 04103
Lübeck, Germany, 23562
Muenchen, Germany, 81377
München, Germany, 81675
Münster, Germany, 48149
Regensburg, Germany, 93053
Tübingen, Germany, 72076
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00372229     History of Changes
Other Study ID Numbers: ML19313
First Submitted: September 5, 2006
First Posted: September 6, 2006
Last Update Posted: October 12, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents