Conditions: Dysfunctional Hemodialysis Catheters
Keywords: HD Hemodialysis Catheter clearance TNKase Renal Insufficiency
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

Brief summary:
This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37 centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: placebo intervention 2: tenecteplase
Intervention descriptions: intervention 1: For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase intervention 2: For the initial treatment, 2 mL of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase

Protocol document: