• 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. ] [ Designated as safety issue: No ]
  Treatment success is defined as Blood Flow Rate (BFR) ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of hemodialysis and at the end of hemodialysis.
  
  
• 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. ] [ Designated as safety issue: No ]
  The primary outcome measure was the number of targeted adverse events, occurring from initial study drug administration through the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for subjects who did not receive open-label, extended-dwell tenecteplase, from initial study administration through the start of Visit 2. Targeted adverse events were defined as intracranial hemorrhage, major bleeding and embolic events, thrombosis, Catheter-related blood stream infection (CRBSIs), and catheter-related complications.
  
  

• 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). ] [ Designated as safety issue: No ]
  For patients with treatment success at Visit 1 or Visit 2, maintenance of catheter function at subsequent visits was defined as a BFR ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated target arterial pressure in the range of 0 to -280 mmHg at the beginning of that HD session (within the first 30 minutes).
  
  
• 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. ] [ Designated as safety issue: No ]

  The urea reduction ratio (URR) was calculated from measurements of blood urea nitrogen (BUN) as follows:

  (Pre-treatment BUN) − (Post-HD BUN) * 100% / (Pre-treatment BUN)

  Pre-treatment URR was assessed within 30-60 minutes after the initiation of HD and does not represent a true baseline value.

  
  
• 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. ] [ Designated as safety issue: No ]

  The urea reduction ratio (URR) at Visit 2 was calculated for those participants who did not receive extended-dwell tenecteplase at Visit 1 from measurements of blood urea nitrogen (BUN) as follows:

  (Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)

  
  
• 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. ] [ Designated as safety issue: No ]
  Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 1 - BFR at Baseline.
  
  
• 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. ] [ Designated as safety issue: No ]
  Patients who failed treatment at Visit 1 and were treated with extended-dwell tenecteplase were analyzed for Treatment Success at Visit 2. Treatment success at Visit 2 was defined as a BFR ≥ 300 mL/min, without line reversal, and increase of ≥ 25 mL/min from baseline BFR, at an associated target arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of HD and at the end of HD.
  
  
• 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) ] [ Designated as safety issue: No ]

  Patients who experienced treatment failure at the end of Visit 1 and were eligible for and treated with extended-dwell tenecteplase at Visit 1 were assessed for Urea Reduction Ratio (URR) at Visits 2 and 3. URR was calculated from blood urea nitrogen (BUN) measurements according to the following:

  (Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)

  
  
• 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). ] [ Designated as safety issue: No ]
  Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 2 - BFR at Baseline.
  
  

The study consisted of four visits that corresponded to consecutive HD sessions for each patient, as well as one follow-up visit. Patients could receive up to three treatments with open-label tenecteplase during the study: one or two treatments during an initial treatment course, and eligible patients whose catheter became dysfunctional again within 21 days of the first visit received an additional treatment as part of a retreatment (RT) course.

At Visit 1, patients eligible at the beginning of HD had 2 mL (2 mg) of tenecteplase instilled into each of the two lumens of the HD catheter. After a dwell time of 1 hour, study drug was withdrawn and all subjects underwent HD. The duration of the HD session was not fixed by the study protocol, but rather by the site's HD practice, physician orders, and individual patient response during the session. Patients who did not experience treatment success at the end of Visit 1 had 2 mL (2 mg) of tenecteplase instilled into each lumen of their catheter as part of the initial treatment course. The treatment was left to dwell for an extended time, until the second HD session at Visit 2 (up to 72 hours later). Patients who received extended-dwell tenecteplase had the treatment withdrawn from their catheter at the beginning of Visit 2. Patients underwent HD as prescribed or to the extent possible.

Patients who had treatment success at Visit 1 or Visit 2 and had a recurrence of catheter dysfunction within 21 days of Visit 1 and met the re-treatment eligibility criteria had 2 mL (2 mg) of tenecteplase instilled into each lumen, followed by a 1-hour dwell time at re-treatment Visit 1.