NCT00396032

A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysfunctional Hemodialysis Catheters

Interventions

Type	Name	Description
DRUG	placebo	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
DRUG	tenecteplase	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

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-12-01
• First posted: 2006-11-06
• Last updated: 2010-06-03
• Results posted: 2010-06-03