Could a daily pill prevent dialysis catheter failures?
NCT ID NCT07404345
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a low-dose blood thinner (apixaban) to the standard heparin lock can help dialysis catheters stay functional longer. Fifty-four adults with end-stage kidney disease and a new catheter will be followed for up to 24 months. The goal is to see if this combination reduces the need for emergency treatments or catheter replacement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Apixaban (a blood thinner) and heparin (a standard catheter lock solution)
- What this could lead to
- If it works, this could reduce the need for emergency procedures or catheter replacements in dialysis patients, making treatment smoother.
- What could go wrong
- This is a small, early-phase trial (54 people) at a single center. The blood thinner may increase bleeding risk, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years with end-stage kidney disease (CKD stage 5) receiving maintenance hemodialysis or initiating hemodialysis. * Recently placed tunneled, double-lumen central venous hemodialysis catheter (tunneled CVC) in place for ≥8 days, with a post-placement radiograph confirming adequate tip position. * Permitted catheter insertion sites: right internal jugular, left internal jugular, right femoral, or left femoral vein. * Adequate initial catheter function, defined as ability to achieve the prescribed extracorporeal blood flow (suggested ≥300 mL/min) for ≥8 days after catheter placement. * Conventional in-center hemodialysis schedule (2-3 sessions/week) at the study unit, with expected ability to complete follow-up for up to 24 months. * Written informed consent provided. * Willingness to receive only the protocol-assigned antithrombotic prophylaxis and to avoid non-study systemic anticoagulants or antiplatelet agents during the study period. Exclusion Criteria: * Non-tunneled hemodialysis catheter, subclavian catheter, or intracaval catheter placement not consistent with the protocol (e.g., catheter located in the SVC/IVC without a subcutaneous tunnel, or catheter location/site not permitted by the study). * Tunneled catheter placed \<8 days before randomization or radiographically confirmed catheter tip malposition at screening. * Active bleeding; active peptic ulcer disease; or clinically significant gastrointestinal bleeding within the past 30 days; uncorrectable INR \>1.5; platelet count \<100,000/µL. * High bleeding risk (HAS-BLED score \>3) or major bleeding that is active or recent. * Known coagulopathy; history of heparin-induced thrombocytopenia (HIT); or allergy/hypersensitivity to heparin, citrate, or rt-PA (alteplase). * Severe hepatic impairment (e.g., Child-Pugh class C), clinically significant liver dysfunction that contraindicates DOAC therapy, or ongoing hemodialysis with regional citrate anticoagulation that cannot be modified per protocol. * Active catheter exit-site infection or bloodstream infection/bacteremia at the time of randomization. * Concomitant use of other systemic anticoagulants (e.g., warfarin, low-molecular-weight heparin, other DOACs) or high-intensity antiplatelet therapy (e.g., dual antiplatelet therapy). * Pregnancy or breastfeeding. * Women of childbearing potential who are unwilling to use a highly effective contraception method during the study and for 48 hours after the last dose of study medication. * Life expectancy \<6 months, current palliative/hospice care, or planned kidney transplant within ≤3 months. * Concurrent participation in another clinical trial that could interfere with the study interventions or outcomes. * Venography demonstrating significant venous stenosis involving the superior vena cava (SVC) or inferior vena cava (IVC).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44200, Mexico
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