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

Phase 3 Completed 150 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2006-10
Primary completion: 2008-12
Completion: —

Outcome

Met primary endpoint

paper After a 1-hour dwell, 22% of patients in the tenecteplase group had functional catheters compared with 5% among placebo controls (P = 0.004). PMID 20133491 ↗

Publications

Tumlin J, Goldman J, Spiegel DM, Roer D, Ntoso KA, Blaney M, Jacobs J, Gillespie BS, Begelman SM. A phase III, randomized, double-blind, placebo-controlled study of tenecteplase for improvement of hemodialysis catheter function: TROPICS 3. Clin J Am Soc Nephrol. 2010 Apr;5(4):631-6. doi: 10.2215/CJN.06520909. Epub 2010 Feb 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenecteplase	Protein / enzyme biologic	2 mg	Other

Indications

No indication recorded.