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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00396032 |
Purpose
This is a Phase III, randomized, double-blind, placebo-controlled study that will be conducted at approximately 40 centers in the United States. Approximately 150 subjects ≥ 16 years of age who require HD and have a dysfunctional HD catheter will be enrolled in the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Insufficiency |
Drug: placebo Drug: tenecteplase |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters |
| Enrollment: | 151 |
| Study Start Date: | October 2006 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: tenecteplase
One or two dose instillation
|
| 2: Placebo Comparator |
Drug: placebo
One or two dose instillation
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
| Study ID Numbers: | N3700g |
| Study First Received: | November 2, 2006 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00396032 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HD Hemodialysis Catheter clearance TNKase |
|
Fibrin Modulating Agents Renal Insufficiency Molecular Mechanisms of Pharmacological Action Urologic Diseases Therapeutic Uses Hematologic Agents |
Tenecteplase Fibrinolytic Agents Cardiovascular Agents Kidney Diseases Pharmacologic Actions |