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

Tracking Information
First Submitted Date  ICMJE September 5, 2006
First Posted Date  ICMJE September 6, 2006
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE May 2006
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
% of patients with active CMV infection within 12 months; % with CMV disease within 12 months; urine proteomic pattern at month 12; time to graft loss
Change History Complete list of historical versions of study NCT00372229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
CMV syndrome or tissue invasive disease; viremia; acute rejection; creatinine clearance; leucopenia and neutropenia; opportunistic infections; graft and patient survival. [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
CMV syndrome or tissue invasive disease; viremia; acute rejection; creatinine clearance; leucopenia and neutropenia; opportunistic infections; graft and patient survival - all assessments made within 12 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cytomegalovirus Infections
Intervention  ICMJE
  • Drug: Pre-emptive therapy
    As prescribed
  • Drug: valganciclovir [Valcyte]
    900mg po for 100 days
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: valganciclovir [Valcyte]
  • Active Comparator: 2
    Intervention: Drug: Pre-emptive therapy
Publications * Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V. Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: Long-term Results After 7 Years of a Randomized Clinical Trial. Transplantation. 2018 May;102(5):876-882. doi: 10.1097/TP.0000000000002024.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2010)
301
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372229
Other Study ID Numbers  ICMJE ML19313
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP