Overview

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

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Treatments:
Tenecteplase
Tissue Plasminogen Activator
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 <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 Criteria: 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