Phase 3 N=150 Randomized Double-blind Treatment

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

Dysfunctional Hemodialysis Catheters

Bottom Line

View on ClinicalTrials.gov: NCT00396032 ↗

Enrolled (actual)

150

Serious AEs

4.0%

Results posted

Jun 2010

Primary outcome: Primary: Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1 — 21.6; 5.3 percentage of success — p=0.0044

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: placebo (Drug); tenecteplase (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Genentech, Inc.
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1	21.6; 5.3	0.0044 sig
PRIMARY Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2	0; 0; 0; 0; 0; 0	—
SECONDARY Change in BFR From Baseline to the End of HD at Visit 1	8.1; 9.3; 58.1; 80.0; 8.1; 2.7	0.0396 sig
SECONDARY Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1)	41.7; 38.5	—
SECONDARY Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2)	11.5; 34.8	—

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.

Eligibility Criteria

Inclusion Criteria

Clinically stable, in the opinion of the investigator
Use of a cuffed, tunneled HD catheter
HD prescribed at a BFR of ≥300 mL/min
Baseline BFR (at any time during the first 60 minutes of HD) of 3.0 within 7 days prior to Visit 1, or a target INR range that allows for an INR >3.0 A laboratory test to confirm the INR must have been performed within 7 days prior to Visit 1.
Initiation of or increase in dose of Plavix® (clopidogrel bisulfate) within 7 days prior to Visit 1
Hemoglobin ≥12.0 g/dL if on an erythropoiesis-stimulating agent (e.g., darbepoetin or erythropoietin) and the dose of the erythropoiesis-stimulating agent has not been held or reduced per institutional policy
At high risk for bleeding events or embolic complications (i.e., recent pulmonary embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constitutes a significant hazard
BFR of <300 mL/min because of symptomatic hypotension
Uncontrolled hypertension in the opinion of the investigator
Known hypersensitivity to tenecteplase or any component of the formulation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00396032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.