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A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters (TROPICS 4)

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00396253
First received: November 2, 2006
Last updated: September 21, 2011
Last verified: September 2011
Results First Received: March 25, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dysfunctional Hemodialysis Catheters
Intervention: Drug: Tenecteplase

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tenecteplase At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).

Participant Flow:   Overall Study
    Tenecteplase  
STARTED     223  
COMPLETED     210  
NOT COMPLETED     13  
Protocol Violation                 1  
Withdrawal by Subject                 7  
Death                 3  
Physician Decision                 1  
Change in eligibility status                 1  



  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.
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Reporting Groups
  Description
Tenecteplase At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).

Baseline Measures
    Tenecteplase  
Number of Participants  
[units: participants]
  223  
Age, Customized  
[units: participants]
 
< 17 years     1  
>= 17 years to < 65 years     120  
>= 65 years     102  
Age  
[units: years]
Mean ± Standard Deviation
  61.2  ± 16.3  
Gender  
[units: participants]
 
Female     124  
Male     99  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1   [ Time Frame: Visit 1 (the first hemodialysis session in which treatment was administered). BFR was measured at the beginning of hemodialysis (Baseline measurement) and at 30 minutes prior to the end of hemodialysis and at the end of hemodialysis. ]

2.  Primary:   Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase   [ Time Frame: From initial study drug administration to the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for patients who did not receive extended-dwell tenecteplase, from initial study administration to the start of Visit 2. ]

3.  Secondary:   Percentage of Participants Who Maintained Catheter Function at Visits 2 and 3   [ Time Frame: Maintenance BFR measurements were taken at the beginning of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) and Visit 3 (3rd consecutive HD session, within 72 hours of Visit 2). ]

4.  Secondary:   Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 1   [ Time Frame: At Visit 1 (first hemodialysis session in which treatment was administered) samples for blood urea nitrogen measurements were taken at the beginning of HD (prior to treatment administration) and after HD was completed. ]

5.  Secondary:   Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 2   [ Time Frame: At Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) samples for blood urea nitrogen measurements were taken prior to HD and after HD was completed. ]

6.  Secondary:   Change in Blood Flow Rate From Baseline to the End of Hemodialysis at Visit 1   [ Time Frame: Baseline (beginning of HD at Visit 1) to the end of HD at Visit 1. ]

7.  Secondary:   Percentage of Participants Who Failed Treatment at Visit 1 With Treatment Success at Visit 2   [ Time Frame: BFR was measured 30 minutes before the end of HD and at the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1). Baseline BFR was measured at the beginning of HD at Visit 1. ]

8.  Secondary:   Percentage of Participants Who Failed Treatment at Visit 1 With a Urea Reduction Ratio ≥ 65% at Visits 2 and 3   [ Time Frame: Blood urea nitrogen measurements were taken prior to HD and at the end of HD at Visits 2 (2nd HD session, within 72 hours after visit 1) and 3 (3rd HD session, within 72 hours of Visit 2) ]

9.  Secondary:   Change in Blood Flow Rate From Baseline to the End of HD at Visit 2   [ Time Frame: Baseline (beginning of HD at Visit 1) to the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1). ]


  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: Genentech, Inc.
phone: 800-821-8590


No publications provided


Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00396253     History of Changes
Other Study ID Numbers: N3701g
Study First Received: November 2, 2006
Results First Received: March 25, 2010
Last Updated: September 21, 2011
Health Authority: United States: Food and Drug Administration