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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00372229
First received: September 5, 2006
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po dail y) prophylaxis with that of no prophylaxis, under the condition of pre-emptive t herapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indire ct effects of active CMV infections will be compared. The anticipated time on st udy treatment is 3 months-1 year, and the target sample size is 100-500 individu als.


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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00372229     History of Changes
Other Study ID Numbers: ML19313
Study First Received: September 5, 2006
Last Updated: October 6, 2014
Health Authority: Germany: Federal Institue for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 23, 2014