Phase 3
N=223
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters
Dysfunctional Hemodialysis Catheters
Bottom Line
View on ClinicalTrials.gov: NCT00396253 ↗Enrolled (actual)
223
Serious AEs
4.0%
Results posted
Aug 2011
Primary outcome: Primary: Percentage of Participants Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1 — 34.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tenecteplase (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1 |
34.1 | — |
| PRIMARY Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase |
0; 0; 0; 1; 2; 0 | — |
| SECONDARY Percentage of Participants Who Maintained Catheter Function at Visits 2 and 3 |
69.4; 62.0 | — |
| SECONDARY Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 1 |
23.8 | — |
| SECONDARY Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 2 |
34.6 | — |
| SECONDARY Change in Blood Flow Rate From Baseline to the End of Hemodialysis at Visit 1 |
81.9 | — |
| SECONDARY Percentage of Participants Who Failed Treatment at Visit 1 With Treatment Success at Visit 2 |
49.1 | — |
| SECONDARY Percentage of Participants Who Failed Treatment at Visit 1 With a Urea Reduction Ratio ≥ 65% at Visits 2 and 3 |
42.2; 33.6 | — |
| SECONDARY Change in Blood Flow Rate From Baseline to the End of HD at Visit 2 |
117.1 | — |
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.
Eligibility Criteria
Inclusion Criteria: for the Study
- Clinically stable, in the opinion of the investigator
- Use of a cuffed, tunneled HD catheter
- HD prescribed at a blood flow rate (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
- 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
Data sourced from ClinicalTrials.gov (NCT00396253). 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.