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IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00294515
First received: February 21, 2006
Last updated: July 30, 2010
Last verified: July 2010
Results First Received: June 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Cytomegalovirus Infections
Intervention: Drug: Valganciclovir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Valganciclovir up to 100 Days 900 mg valganciclovir orally daily for up to 100 days
Valganciclovir up to 200 Days 900 mg valganciclovir orally daily for up to 200 days

Participant Flow:   Overall Study
    Valganciclovir up to 100 Days     Valganciclovir up to 200 Days  
STARTED     166 [1]   160 [1]
COMPLETED     132     132  
NOT COMPLETED     34     28  
[1] Randomized



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Valganciclovir up to 100 Days 900 mg valganciclovir orally daily for up to 100 days
Valganciclovir up to 200 Days 900 mg valganciclovir orally daily for up to 200 days
Total Total of all reporting groups

Baseline Measures
    Valganciclovir up to 100 Days     Valganciclovir up to 200 Days     Total  
Number of Participants  
[units: participants]
  164     156     320  
Age [1]
[units: years]
Mean ± Standard Deviation
  48.5  ± 13.76     47.0  ± 13.51     47.8  ± 13.64  
Gender [1]
[units: participants]
     
Female     45     40     85  
Male     119     116     235  
[1] Safety population



  Outcome Measures
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1.  Primary:   Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant   [ Time Frame: 12 months post-transplant ]

2.  Secondary:   Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant   [ Time Frame: 6 months post-transplant ]

3.  Secondary:   Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant   [ Time Frame: 9 months post-transplant ]

4.  Secondary:   Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant   [ Time Frame: 18 months post-transplant ]

5.  Secondary:   Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant   [ Time Frame: 24 months post-transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00294515     History of Changes
Other Study ID Numbers: NT18435
Study First Received: February 21, 2006
Results First Received: June 2, 2010
Last Updated: July 30, 2010
Health Authority: United States: Food and Drug Administration