A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters (TROPICS 3)

Genentech

Status and phase

Completed

Phase 3

Conditions

Dysfunctional Hemodialysis Catheters

Treatments

Drug: tenecteplase

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00396032

N3700g

Details and patient eligibility

About

This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37 centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.

Enrollment

150 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinically stable, in the opinion of the investigator
Use of a cuffed, tunneled HD catheter
HD prescribed at a 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

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 A laboratory test to confirm the INR must have been performed within 7 days prior to Visit 1.
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