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A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters (TROPICS 3)
This study has been completed.
First Received: November 2, 2006   Last Updated: August 7, 2009   History of Changes
Sponsor: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00396032
  Purpose

This is a Phase III, randomized, double-blind, placebo-controlled study that will be conducted at approximately 40 centers in the United States. Approximately 150 subjects ≥ 16 years of age who require HD and have a dysfunctional HD catheter will be enrolled in the study.


Condition Intervention Phase
Renal Insufficiency
Drug: placebo
Drug: tenecteplase
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of targeted adverse events from initial study drug administration through the start of Visit 2 [ Time Frame: Visits 1 and 2 ] [ Designated as safety issue: No ]
  • Percentage of subjects who have treatment success with respect to BFR at Visit 1 [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • For subjects who have treatment success at Visit 1, the percentage of subjects who maintain catheter function at Visits 2 and 3 [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Percentage of subjects with a urea reduction ratio (URR) of ≥ 65% as assessed by pretreatment and post-HD blood urea nitrogen (BUN) measurements at Visit 1 [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • For subjects who do not receive open-label tenecteplase at Visit 2, the percentage of subjects with a URR of ≥ 65% as assessed by pre- and post-HD BUN measurements at Visit 2 [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
  • Change in BFR from baseline to the end of HD at Visit 1 [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • Percentage of subjects who fall into each of the following categories defined by change in BFR from baseline to the end of HD at Visit 1: < 0 mL/min, 0-24 mL/min, 25-49 mL/min, 50-99 mL/min, 100-149 mL/min, and ≥ 150 mL/min [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: October 2006
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: tenecteplase
One or two dose instillation
2: Placebo Comparator Drug: placebo
One or two dose instillation

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (during the first 30 minutes of HD) of < 300 mL/min (using catheter lines in the customary direction, prior to any reversal of lines; see Section 3.1.2.a) at an arterial pressure of -250 mmHg (or at institutional guidelines for maximum negative arterial pressure, not to exceed 250 mmHg)
  • Baseline BFR (during the first 30 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 -250 mmHg in at least one HD session in the 7 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 implanted in the subclavian vein
  • Anticipated use of catheter for any other type of diagnostic or therapeutic procedure (i.e., other than HD) during the course of the study
  • Previously treated in this study or any tenecteplase catheter clearance trial
  • Use of any investigational drug or therapy 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
  • HD catheter with known or suspected infection
  • History of any intracranial hemorrhage, aneurysm, or arteriovenous malformation
  • Use of any heparin (unfractionated or low molecular weight) within 24 hours prior to Visit 1, except for heparin used only during HD or for prophylaxis (e.g., heparin lock)
  • Use of warfarin within 7 days prior to Visit 1, except for low-dose warfarin used for prophylaxis
  • Initiation of or increase in dose of Plavix(R) (clopidogrel bisulfate) within 7 days prior to Visit 1
  • Hemoglobin ≥ 13.5 g/dL if on erythropoietin
  • Platelet count < 75,000/uL
  • 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 (e.g., systolic pressure > 185 mmHg and diastolic pressure > 110 mmHg)
  • Known hypersensitivity to tenecteplase or any component of the formulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396032

Sponsors and Collaborators
Genentech
Investigators
Study Director: Barbara Gillespie, M.D., FASN Quintiles
  More Information

No publications provided

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: N3700g
Study First Received: November 2, 2006
Last Updated: August 7, 2009
ClinicalTrials.gov Identifier: NCT00396032     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
HD
Hemodialysis
Catheter clearance
TNKase

Additional relevant MeSH terms:
Fibrin Modulating Agents
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Urologic Diseases
Therapeutic Uses
Hematologic Agents
Tenecteplase
Fibrinolytic Agents
Cardiovascular Agents
Kidney Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009