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

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Abstract

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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Acknowledgments

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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Authors and Affiliations

  1. Division of Nephrology, Winthrop-University Hospital, 200 Old Country Rd, #135, Mineola, NY, 11501, USA

    Steven Fishbane

  2. Nephrology, Inc, Mishawaka, IN, USA

    Samuel L. Milligan

  3. Department of Sponsored Research, ProMedica Health System, Toledo, OH, USA

    Kenneth D. Lempert

  4. Nephrology Associates, Augusta, GA, USA

    Joachim E. W. Hertel

  5. Division of Nephrology and Hypertension, University of Kansas Medical Center, Kansas City, KS, USA

    James B. Wetmore

  6. Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

    Matthew J. Oliver

  7. Department of Medical Affairs, Genentech, Inc, South San Francisco, CA, USA

    Martha Blaney, Joan R. Jacobs & Susan M. Begelman

  8. Department of Medical and Scientific Services, Quintiles, Morrisville, NC, USA

    Barbara S. Gillespie

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  1. Steven Fishbane
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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). https://doi.org/10.1007/s11239-010-0493-1

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  • DOI: https://doi.org/10.1007/s11239-010-0493-1

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