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A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters

NCT00396253 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2017-01-12

Study results available
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Summary

This was a Phase III, open-label study conducted at 44 centers in the United States, Canada, and Puerto Rico. 223 subjects who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.

Conditions

  • Dysfunctional Hemodialysis Catheters

Interventions

DRUG

Tenecteplase

2 mL (2 mg) of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara Gillespie, MD, FASN · Quintiles, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-10-31
Completion
2008-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00396253 on ClinicalTrials.gov