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Improvement of Hemodialysis Catheter Function with Tenecteplase: A Phase III, Open-Label Study: TROPICS 4


Hemodialysis (HD) catheters are prone to thrombotic occlusion. We evaluated tenecteplase, a thrombolytic, for the treatment of dysfunctional HD catheters. Patients with tunneled HD catheters and blood flow rate (BFR) <300 mL/min received open-label tenecteplase (2 mg/lumen) for a 1 h intracatheter dwell. Treatment success was defined as BFR ≥300 mL/min and a ≥25 mL/min increase from baseline BFR, 30 min before and at the end of HD. Patients without treatment success at the end of the initial visit received another 2 mg dose of tenecteplase for an up to 72 h extended dwell. Of 223 enrolled patients, 34% (95% confidence interval [CI], 28–40%) had treatment success after a 1 h dwell. Mean (standard deviation [SD]) BFR change from baseline was 82 (124) mL/min. Treatment success in those who received extended-dwell tenecteplase (n = 116) was 49% (95% CI, 40–58%), with mean (SD) BFR change from baseline of 117 (140) mL/min. Reported targeted adverse events included five catheter-related bloodstream infections and one thrombosis. No intracranial hemorrhage, major bleeding, embolic events, or catheter-related complications were reported. Tenecteplase administered as a 1 h or 1 h plus extended dwell was associated with improved HD catheter function in the TROPICS 4 trial.

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This study was sponsored by Genentech, Inc. Support for third-party medical writing assistance was provided by Genentech, Inc. Steven Fishbane has received research support from Genentech; Samuel Milligan has nothing to declare; Kenneth Lempert has nothing to declare; Joachim Hertel has received research support from Genentech; James Wetmore has nothing to declare; Matthew Oliver has nothing to declare; Martha Blaney is an employee of Genentech and has stock ownership interest in Roche; Barbara Gillespie is employed by Quintiles, Inc, the research organization that was contracted by Genentech to execute the TROPICS trials; Joan Jacobs is an employee of Genentech and has stock ownership interest in Roche; Susan Begelman is an employee of Genentech and has stock ownership interest in Roche.

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Correspondence to Steven Fishbane.

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Fishbane, S., Milligan, S.L., Lempert, K.D. et al. Improvement of Hemodialysis Catheter Function with Tenecteplase: A Phase III, Open-Label Study: TROPICS 4. J Thromb Thrombolysis 31, 99–106 (2011).

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  • Chronic renal failure
  • Dialysis catheter
  • End-stage renal disease
  • Hemodialysis
  • Tenecteplase
  • Thrombolytic