Dysfunctional Hemodialysis CathetersPhase 3TROPICS 3NCT00396032
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters
A Phase 3 study testing tenecteplase in people with Dysfunctional Hemodialysis Catheters, run by Genentech, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dysfunctional Hemodialysis Catheters
- What is being tested?
- tenecteplase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Dysfunctional Hemodialysis Catheters
- Being tested
- placebo, tenecteplase
- Keywords
- HD, Hemodialysis, Catheter clearance, TNKase, Renal Insufficiency
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
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
tenecteplaseDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: tenecteplase |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1
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.
Measured: Visit 1 of HD treatment
Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2
Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications
Measured: Visits 1 and 2 of consecutive HD treatments
Secondary outcomes (3)
Change in BFR From Baseline to the End of HD at Visit 1
BFR is measured in mL/minute.
Measured: Visit 1 of HD treatment
Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1)
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.
Measured: Visit 2 of consecutive HD treatments
Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2)
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.
Measured: Visit 2 of consecutive HD treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional Hemodialysis CathetersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barbara Gillespie, M.D., FASN, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396032
- Sponsor's protocol ID
- N3700g
- Acronym
- TROPICS 3
- Status last verified
- May 2010
- First submitted
- 2 Nov 2006
- Last updated
- 3 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 20133491
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters
- ClinicalTrials.gov ID
- NCT00396032
- Acronym / sponsor ID
- TROPICS 3 / N3700g
- Conditions
- Dysfunctional Hemodialysis Catheters
- Keywords
- HD, Hemodialysis, Catheter clearance, TNKase, Renal Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- First posted
- 6 Nov 2006 (estimated)
- Results
- Posted 3 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tenecteplase |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboFor 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 | 2 |
| tenecteplaseFor 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 | Drug | 1 |
Primary outcome
Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1
Time frame: Visit 1 of HD treatment
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
Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications
3 secondary outcomes
Change in BFR From Baseline to the End of HD at Visit 1
Time frame: Visit 1 of HD treatment
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20133491Tumlin 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Gillespie, M.D., FASN study director
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tenecteplase in people with Dysfunctional Hemodialysis Catheters, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2010.