PatencyPhase 3NCT02036255
Prevention of Dialysis Catheter Malfunction With Prophylactic Use of a Taurolidine Containing Urokinase
A Phase 3 study testing Taurolidine Urokinase and Taurolidine Heparin in people with Patency and Infection, run by Universitair Ziekenhuis Brussel at 9 sites in Belgium.
Trial summary
The objective of our study is to investigate whether the substitution of the standard locking solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U 25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis patients with a history of TCC dysfunction… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- Taurolidine Urokinase and Taurolidine Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 9 sitesBelgium
- Study dates
- May 2015to May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, prevalent hemodialysis patients
- Informed and consented
- Hemodialysis 3x/week via a tunneled cuffed catheter
- Urokinase administration at least two times during the previous 6 months (with more than a week between 2 administrations)
- Adequate catheter function during the week before inclusion (defined by blood flow more than 250ml/min on each dialysis session and blood flow within 15% of the maximal blood flow after the last Urokinase administration)
Who cannot join
- Presence of heparin-induced thrombocytopenia
- Major hemorrhage or intracranial bleeding in the previous 3 months
- Pericarditis
- Intolerance to Taurolidine, citrate or to Urokinase
- Active catheter-related infection
- Catheter in the femoral vein
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Belgium9 sites
Bracops Hospital
Anderlecht, Brussels Capital, 1070
UZ Antwerpen
Antwerp
Ixelles Hospital
Brussels, 1050
CHU Charleroi
Charleroi, Hainaut
Ghent Hospital
Ghent
Ixelles Hospital
Ixelles-Elsene, Brussels Capital, 1050
Brugman Hospital
Jette, Brussels Capital, 1090
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
CHWAPI
Tournai, Hainaut, 7500
About this study
Official title: Prevention of Tunneled Cuffed Catheter Malfunction With Prophylactic Use of a Taurolidine Locking Solution Containing Urokinase : a Multicentric Randomized Controlled Trial
The objective of our study is to investigate whether the substitution of the standard locking solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U 25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis patients with a history of TCC dysfunction requiring urokinase therapy.
- Being tested
- Taurolidine Urokinase, Taurolidine Heparin
- Keywords
- Prevention, Thrombosis, Hemodialysis, Vascular access device
- Medical subject headings
- Infections, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurolidine UrokinaseDrug
Also called Taurolock Urokinase 25,000
Taurolidine HeparinDrug
Also called Taurolock HEP 500
| Study group | Role | What they receive |
|---|---|---|
| Taurolidine Urokinase | Experimental | Taurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500 Receives: Drug: Taurolidine Urokinase; Drug: Taurolidine Heparin |
| Taurolidine Heparin | Active comparator | Taurolock HEP 500 is used as locking solution after each dialysis session Receives: Drug: Taurolidine Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement of Urokinase
Requirement of Urokinase for thrombotic malfunction of dialyse catheter
Measured: 6 months
Secondary outcomes (1)
Removal of dialysis catheter
Removal of dialysis catheter for thrombosis and for bacteremia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startMay 2015
- Primary completionJul 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PatencyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bonkain Florence, Universitair Ziekenhuis Brussel
- Investigators
- Florence FB Bonkain, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036255
- Sponsor's protocol ID
- TL-001
- Status last verified
- May 2018
- First submitted
- 11 Jan 2014
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hemmelgarn BR, Moist LM, Lok CE, Tonelli M, Manns BJ, Holden RM, LeBlanc M, Faris P, Barre P, Zhang J, Scott-Douglas N; Prevention of Dialysis Catheter Lumen Occlusion with rt-PA versus Heparin Study Group. Prevention of dialysis catheter malfunction with recombinant tissue plasminogen activator. N Engl J Med. 2011 Jan 27;364(4):303-12. doi: 10.1056/NEJMoa1011376.
PubMed 21268722Trerotola SO, Johnson MS, Harris VJ, Shah H, Ambrosius WT, McKusky MA, Kraus MA. Outcome of tunneled hemodialysis catheters placed via the right internal jugular vein by interventional radiologists. Radiology. 1997 May;203(2):489-95. doi: 10.1148/radiology.203.2.9114110.
PubMed 9114110Di Iorio BR, Bellizzi V, Cillo N, Cirillo M, Avella F, Andreucci VE, De Santo NG. Vascular access for hemodialysis: the impact on morbidity and mortality. J Nephrol. 2004 Jan-Feb;17(1):19-25.
PubMed 15151255Bonkain F, Stolear JC, Catalano C, Vandervelde D, Treille S, Couttenye MM, Dhondt A, Libertalis M, Allamani M, Madhoun P, Van Craenenbroeck AH, Vanommeslaeghe F, Van Hulle F, Durieux P, Van Limberghen I, Tielemans C, Wissing KM. Prevention of tunneled cuffed catheter dysfunction with prophylactic use of a taurolidine urokinase lock: A randomized double-blind trial. PLoS One. 2021 May 20;16(5):e0251793. doi: 10.1371/journal.pone.0251793. eCollection 2021.
PubMed 34015014Bonkain F, Van Hulle F, Janssens P, Catalano C, Allamani M, Stolear JC, Vandervelde D, Libertalis M, Treille S, Couttenye MM, Dhondt A, Van Biesen W, Fils JF, Tielemans C, Wissing KM. Urokinase-containing locking solution in the prevention of dialysis catheter dysfunction: a double blind randomized controlled trial. J Vasc Access. 2017 Sep 11;18(5):436-442. doi: 10.5301/jva.5000737. Epub 2017 Jun 14.
PubMed 28623638
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Tunneled Cuffed Catheter Malfunction With Prophylactic Use of a Taurolidine Locking Solution Containing Urokinase : a Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02036255
- Acronym / sponsor ID
- TL-001
- Keywords
- Prevention, Thrombosis, Hemodialysis, Vascular access device
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of our study is to investigate whether the substitution of the standard locking solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U 25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis patients with a history of TCC dysfunction requiring urokinase therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taurolidine Urokinase | Experimental | Drug: Taurolidine Urokinase, Drug: Taurolidine HeparinTaurolock Urokinase is used weekly in this arm substituting the classic Taurolock HEP500 |
| Taurolidine Heparin | Active comparator | Drug: Taurolidine HeparinTaurolock HEP 500 is used as locking solution after each dialysis session |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult, prevalent hemodialysis patients
- Informed and consented
- Hemodialysis 3x/week via a tunneled cuffed catheter
- Urokinase administration at least two times during the previous 6 months (with more than a week between 2 administrations)
- Adequate catheter function during the week before inclusion (defined by blood flow more than 250ml/min on each dialysis session and blood flow within 15% of the maximal blood flow after the last Urokinase administration)
Key exclusion criteria (6 listed)
- Presence of heparin-induced thrombocytopenia
- Major hemorrhage or intracranial bleeding in the previous 3 months
- Pericarditis
- Intolerance to Taurolidine, citrate or to Urokinase
- Active catheter-related infection
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 |
|---|---|---|
| Taurolidine UrokinaseAlso: Taurolock Urokinase 25,000 | Drug | Taurolidine Urokinase |
| Taurolidine HeparinAlso: Taurolock HEP 500 | Drug | Taurolidine Heparin, Taurolidine Urokinase |
Primary outcome
Requirement of Urokinase
Time frame: 6 months
Requirement of Urokinase for thrombotic malfunction of dialyse catheter
1 secondary outcome
Removal of dialysis catheter
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 21268722Hemmelgarn BR, Moist LM, Lok CE, Tonelli M, Manns BJ, Holden RM, LeBlanc M, Faris P, Barre P, Zhang J, Scott-Douglas N; Prevention of Dialysis Catheter Lumen Occlusion with rt-PA versus Heparin Study Group. Prevention of dialysis catheter malfunction with recombinant tissue plasminogen activator. N Engl J Med. 2011 Jan 27;364(4):303-12. doi: 10.1056/NEJMoa1011376.
- Background: PubMed 9114110Trerotola SO, Johnson MS, Harris VJ, Shah H, Ambrosius WT, McKusky MA, Kraus MA. Outcome of tunneled hemodialysis catheters placed via the right internal jugular vein by interventional radiologists. Radiology. 1997 May;203(2):489-95. doi: 10.1148/radiology.203.2.9114110.
- Background: PubMed 15151255Di Iorio BR, Bellizzi V, Cillo N, Cirillo M, Avella F, Andreucci VE, De Santo NG. Vascular access for hemodialysis: the impact on morbidity and mortality. J Nephrol. 2004 Jan-Feb;17(1):19-25.
- Derived from this study: PubMed 34015014Bonkain F, Stolear JC, Catalano C, Vandervelde D, Treille S, Couttenye MM, Dhondt A, Libertalis M, Allamani M, Madhoun P, Van Craenenbroeck AH, Vanommeslaeghe F, Van Hulle F, Durieux P, Van Limberghen I, Tielemans C, Wissing KM. Prevention of tunneled cuffed catheter dysfunction with prophylactic use of a taurolidine urokinase lock: A randomized double-blind trial. PLoS One. 2021 May 20;16(5):e0251793. doi: 10.1371/journal.pone.0251793. eCollection 2021.
- Derived from this study: PubMed 28623638Bonkain F, Van Hulle F, Janssens P, Catalano C, Allamani M, Stolear JC, Vandervelde D, Libertalis M, Treille S, Couttenye MM, Dhondt A, Van Biesen W, Fils JF, Tielemans C, Wissing KM. Urokinase-containing locking solution in the prevention of dialysis catheter dysfunction: a double blind randomized controlled trial. J Vasc Access. 2017 Sep 11;18(5):436-442. doi: 10.5301/jva.5000737. Epub 2017 Jun 14.
Related trials for Patency
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
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.
Florence FB Bonkain, MD principal investigator
Universitair Ziekenhuis Brussel
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Taurolidine Urokinase and Taurolidine Heparin in people with Patency and Infection, run by Universitair Ziekenhuis Brussel at 9 sites in Belgium.
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 5 inclusion and 6 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Requirement of Urokinase (time frame: 6 months). 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 NCT02036255, which also lists 5 linked publications.
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 May 2018.