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

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

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). ]