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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00372229
First received: September 5, 2006
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  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: valganciclovir [Valcyte]
Drug: Pre-emptive therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ 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 ]

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 ]

Enrollment: 301
Study Start Date: May 2006
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372229

Locations
Austria
Innsbruck, Austria, 6020
Wien, Austria, 1090
Germany
Aachen, Germany, 52057
Berlin, Germany, 12203
Berlin, Germany, 13353
Bremen, Germany, 28177
Düsseldorf, Germany, 40225
Erlangen, Germany, 91054
Essen, Germany, 45147
Frankfurt Am Main, Germany, 60590
Freiburg, Germany, 79106
Hamburg, Germany, 20251
Hann. Münden, Germany, 34346
Hannover, Germany, 30625
Jena, Germany, 07747
Koeln, Germany, 50931
Leipzig, Germany, 04103
Lübeck, Germany, 23562
München, Germany, 81675
München, Germany, 81377
Münster, Germany, 48149
Regensburg, Germany, 93053
Tübingen, Germany, 72076
Würzburg, Germany, 97080
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00372229     History of Changes
Other Study ID Numbers: ML19313
Study First Received: September 5, 2006
Last Updated: November 22, 2011
Health Authority: Germany: Federal Institue for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on June 18, 2013