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

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. Identifier: NCT00372229
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
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
Study Start Date : May 2006
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: 1 Drug: valganciclovir [Valcyte]
900mg po for 100 days

Active Comparator: 2 Drug: Pre-emptive therapy
As prescribed

Primary Outcome Measures :
  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 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00372229

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Innsbruck, Austria, 6020
Wien, Austria, 1090
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
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Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT00372229     History of Changes
Other Study ID Numbers: ML19313
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents