Status:
COMPLETED
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters
Lead Sponsor:
Genentech, Inc.
Conditions:
Dysfunctional Hemodialysis Catheters
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 enrol...
Detailed Description
The study consisted of four visits that corresponded to consecutive HD sessions for each patient, as well as one follow-up visit. Patients could receive up to three treatments with open-label tenectep...
Eligibility Criteria
Inclusion
- 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 \<300 mL/min at an associated pre-pump negative arterial pressure in the range between and including -240 mmHg and -280 mmHg
- Baseline BFR (at any time during the first 60 minutes of HD) at least 25 mL/min below the prescribed BFR
- Demonstrated BFR of ≥300 mL/min (using catheter lines in the customary direction) at an arterial pressure in the range of 0 to -280 mmHg in at least one HD session in the 14 days prior to Visit 1
- Anticipated use of the same catheter for at least four consecutive HD sessions, on the same type and model of HD apparatus
- Able to have fluids infused at the volume necessary to instill study drug into the HD catheter
Exclusion
- for the Study
- HD catheter with sustainable BFR of ≥300 mL/min following subject repositioning
- HD catheter inserted \<2 days prior to screening
- Evidence of a mechanical, non-thrombotic cause of HD catheter dysfunction (e.g., kink in the catheter or suture constricting the catheter) or dysfunction caused by known fibrin sheath
- Use of an implantable port
- HD catheter that is internally coated with any therapeutic agent (e.g., the Decathlon™ Gold catheter)
- Anticipated use of catheter for any other type of diagnostic or therapeutic procedure (i.e., other than HD) during study drug treatment
- Previously treated in this study or any tenecteplase catheter clearance trial
- Use of any investigational drug or therapy (defined as any drug or therapy that is not FDA approved) within 28 days prior to screening
- Use of a fibrinolytic agent (e.g. alteplase, tenecteplase, reteplase, or urokinase) within 7 days prior to Visit 1
- Known to be pregnant or breastfeeding at screening or at Visit 1
- Known bacteremia or known or suspected infection in the HD catheter
- Known history of any of the following: intracranial hemorrhage (within the previous 3 years), intracranial aneurysm, or arteriovenous malformation
- Use of heparin (unfractionated or low molecular weight) or other anticoagulants (e.g., for the treatment of heparin-induced thrombocytopenia) within 24 hours prior to Visit 1, except for heparin used only during HD or for prophylaxis (e.g., heparin lock or deep vein thrombosis prophylaxis)
- Subjects treated with warfarin only: international normalized ratio (INR) \>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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT00396253
Start Date
November 1 2006
End Date
October 1 2008
Last Update
January 12 2017
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