A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters - Study Results

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

This study has been completed.

Study NCT00396032 Information provided by Genentech

First Received on November 2, 2006. Last Updated on May 1, 2010 History of Changes

Results First Received: March 24, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Dysfunctional Hemodialysis Catheters
Interventions:	Drug: placebo Drug: tenecteplase

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was randomized but not treated, therefore the modified intent-to-treat (MITT) analysis population was 149.

Reporting Groups

	Description
Tenecteplase	For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
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

Participant Flow: Overall Study

	Tenecteplase	Placebo
STARTED	74	76
COMPLETED	70	71
NOT COMPLETED	4	5

Baseline Characteristics

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Reporting Groups

	Description
Tenecteplase	For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
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

Baseline Measures

	Tenecteplase	Placebo	Total
Number of Participants [units: participants]	74	75	149
Age, Customized [units: participants]
< 17 years	0	0	0
>= 17 years to < 65 years	44	51	95
>= 65 years	30	24	54
Age [units: years] Mean ± Standard Deviation	60.8 ± 14.1	57.8 ± 16.5	59.3 ± 15.3
Gender [units: participants]
Female	38	37	75
Male	36	38	74

Outcome Measures

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1. Primary:

Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1 [ Time Frame: Visit 1 of HD treatment ]

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2. Primary:

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 ]

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3. Secondary:

Change in BFR From Baseline to the End of HD at Visit 1 [ Time Frame: Visit 1 of HD treatment ]

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4. Secondary:

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 ]

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5. Secondary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800-821-8590

No publications provided by Genentech

Publications automatically indexed to this study:

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. Epub 2010 Feb 4.

Responsible Party:	Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00396032 History of Changes
Other Study ID Numbers:	N3700g
Study First Received:	November 2, 2006
Results First Received:	March 24, 2010
Last Updated:	May 1, 2010
Health Authority:	United States: Food and Drug Administration