a study of tenecteplase for restoration of function in dysfunctional hemodialysis catheters

Conditions: Dysfunctional Hemodialysis Catheters

Summary: 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.


Eligibility criteria:
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

Keywords: hd hemodialysis catheter clearance tnkase renal insufficiency