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

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00396032
First received: November 2, 2006
Last updated: May 1, 2010
Last verified: May 2010

November 2, 2006
May 1, 2010
October 2006
December 2008   (final data collection date for primary outcome measure)
  • Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1 [ Time Frame: Visit 1 of HD treatment ] [ Designated as safety issue: No ]
    Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.
  • Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2 [ Time Frame: Visits 1 and 2 of consecutive HD treatments ] [ Designated as safety issue: No ]
    Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications
  • The primary efficacy outcome measure is the percentage of subjects who have treatment success at Visit 1
  • Incidence of targeted adverse events (intracranial hemorrhages, major bleeding, embolic events, thrombosis, catheter-related blood stream infections, and catheter-related complications) from initial study drug administration through the start of Visit 2.
Complete list of historical versions of study NCT00396032 on ClinicalTrials.gov Archive Site
  • Change in BFR From Baseline to the End of HD at Visit 1 [ Time Frame: Visit 1 of HD treatment ] [ Designated as safety issue: No ]
    BFR is measured in mL/minute.
  • Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1) [ Time Frame: Visit 2 of consecutive HD treatments ] [ Designated as safety issue: No ]
    Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.
  • Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2) [ Time Frame: Visit 2 of consecutive HD treatments ] [ Designated as safety issue: No ]
    Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.
  • For subjects who have treatment success at Visit 1, the percentage of subjects who maintain catheter patency at Visits 2 and 3
  • Percentage of subjects with a urea reduction ratio (URR) of ≥ 65% as assessed by pre- and post-HD BUN measurements at Visit 1
  • Percent improvement from baseline BFR at the end of HD at Visit 1
  • Percentage of subjects who fall into categories defined by change from baseline BFR at the end of HD at Visit 1
  • Percentage of subjects who have treatment success at Visit 2
  • For subjects who have treatment success at Visit 2, the percentage of subjects who maintain catheter patency at Visits 3 and 4
  • Percentage of subjects with a URR of ≥ 65% as assessed by pre- and post-HD BUN measurements at Visit 2
  • Percent improvement from baseline BFR at the end of HD at Visit 2
  • Percentage of subjects who fall into categories defined by change from baseline BFR at the end of HD at Visit 2
  • Incidence of targeted adverse events from the start of Visit 2 through completion of the second visit following the last administration of study treatment
  • Incidence of all adverse events from initial study drug administration through the start of Visit 2
  • Incidence of all adverse events from the start of Visit 2 through completion of the second visit following the last administration of study treatment.
Not Provided
Not Provided
 
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dysfunctional Hemodialysis Catheters
  • Drug: placebo
    For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
  • Drug: tenecteplase
    For the initial treatment, 2 mL of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
  • Experimental: 1
    Intervention: Drug: tenecteplase
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Tumlin J, Goldman J, Spiegel DM, Roer D, Ntoso KA, Blaney M, Jacobs J, Gillespie BS, Begelman SM. A phase III, randomized, double-blind, placebo-controlled study of tenecteplase for improvement of hemodialysis catheter function: TROPICS 3. Clin J Am Soc Nephrol. 2010 Apr;5(4):631-6. doi: 10.2215/CJN.06520909. Epub 2010 Feb 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Not Provided
December 2008   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00396032
N3700g
Not Provided
Clinical Trials Posting Group, Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Barbara Gillespie, M.D., FASN
Genentech, Inc.
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP