Hemodialysis Access FailurePhase 4APICATH-HDNCT07404345
Low-Dose Apixaban Added to Standard Heparin Lock Versus Heparin Lock Alone to Prevent Tunneled Hemodialysis Catheters Dysfunction (APICATH-HD)
A Phase 4 study testing Apixaban and Heparin sodium lock solution in people with Hemodialysis Access Failure and Kidney Disease, End-Stage, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
This randomized, single-center, PROBE trial evaluates whether adding low-dose apixaban (2.5 mg orally every 12 hours) to standard intraluminal heparin lock prolongs primary functional patency of tunneled hemodialysis catheters compared with standard heparin lock alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Access Failure, Kidney Disease, End-Stage, Hemodialysis Catheter
- What is being tested?
- Apixaban and Heparin sodium lock solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2026to 1 Sep 2028
- Phase
- Phase 4
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44200
Jenifer M Lnagarica Lopez, Nephrology Fellow, +523221127583, jeni.langarica@gmail.com
Manuel Arizaga Napoles, Neprhologist, +523317476634, man.arizaga.napoles@gmail.com
About this study
Official title: Efficacy of Low-Dose Apixaban Added to Standard Heparin Lock to Prevent Dysfunction of Tunneled Hemodialysis Catheters: A Randomized, PROBE, Parallel-Grupo Trial.
This randomized, single-center, PROBE trial evaluates whether adding low-dose apixaban (2.5 mg orally every 12 hours) to standard intraluminal heparin lock prolongs primary functional patency of tunneled hemodialysis catheters compared with standard heparin lock alone. Adult patients on hemodialysis with a recently implanted, functioning tunneled catheter (≥8 days) will be randomized 1:1 and followed up to 24 months (or until catheter loss). Primary outcome is time to first intervention for catheter dysfunction or definitive catheter loss. Secondary outcomes include primary-assisted and secondary patency, thrombotic dysfunction, rescue procedures, catheter-related infection, bleeding (ISTH), and mortality. Outcomes adjudication will be blinded.
Read the detailed description
Design: Single-center, randomized (1:1), parallel-group, superiority trial with a PROBE strategy (open-label clinical management; blinded outcome adjudication by an independent committee).
Arms / Interventions Arm 1: Control - Heparin Lock Alone
Intervention Name:
Heparin Lock
Description:
Intraluminal heparin lock after each hemodialysis session as standard care. Heparin concentration is 1,000 IU/mL, with per-lumen volume equal to the priming volume specified by the catheter manufacturer.
Arm 2: Intervention - Apixaban Plus Heparin Lock
Intervention Name:
Apixaban
Description:
Intraluminal heparin lock identical to the control arm (standard care; heparin 1,000 IU/mL with per-lumen volume according to device priming volume), plus systemic anticoagulation with apixaban 2.5 mg orally every 12 hours.
Population: Adults (≥18 years) on hemodialysis with a tunneled double-lumen catheter (Palindrome®) in the internal jugular (right/left) or femoral (right/left) position, functioning and ≥8 days post-implantation, without early dysfunction.
Procedures: Per dialysis session, record prescribed/achieved blood flow, inline pressures, alarms, recirculation, line inversion, and lock details; document formal interventions for dysfunction (rt-PA instillation, related angioplasty, over-the-wire exchange), and evaluate infections using CDC criteria.
Follow-up: Each dialysis session and monthly safety/adherence checks; administrative censoring at 24 months or upon catheter loss/replacement, refractory infection, switch to AV access, transplant, death, or end of study.
Safety: Bleeding surveillance (ISTH). Temporary interruption rules for procedures/bleeding/concomitant drugs. Independent DSMB with one interim analysis at ~50% of primary events using O'Brien-Fleming boundaries.
- Being tested
- Apixaban, Heparin sodium lock solution
- Keywords
- Hemodialysis, Tunneled central venous catheter, Catheter dysfunction, Catheter Failure, Catheter thrombosis, Apixaban, Heparin lock, End-stage kidney disease, Vascular access, Anticoagulation, PROBE trial
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Apixaban 2.5 mg orally every 12 hours, initiated after randomization (TO) and continued until administrative censoring at 24 months or earlier catheter loss/removal/exchange, modality change, kidney transplant, withdrawal, death, or end of study. Temporary interruptions, bleeding events, and adherence are recorded per protocol.
Heparin sodium lock solutionDrug
Heparin sodium catheter lock solution (1,000 IU/mL) instilled into each lumen of the tunneled hemodialysis catheter at the end of each dialysis session, using a volume equal to the catheter manufacturer's priming volume per lumen. The same lock protocol is used in both study arms.
| Study group | Role | What they receive |
|---|---|---|
| Heparin sodium lock solution | Active comparator | Heparin sodium catheter lock solution (1,000 IU/ mL) instilled into each lumen of the tunneled hemodialysis catheter at the end of each dialysis session, using a volume equal to the catheter manufacturer's priming volume per lumen. The same lock protocol is used in both study arms. Receives: Drug: Heparin sodium lock solution |
| Apixaban | Experimental | Standard catheter care including intraluminal heparin lock per unit protocol, plus apixaban 2.5 mg orally every 12 hours, initiated after randomization (T0) and continued until administrative censoring at 24 months or earlier catheter loss/removal/exchange, modality change, kidney transplant, withdrawal, death, or end of study. Temporary interruptions, bleeding events, and adherence are recorded per protocol. Receives: Drug: Apixaban; Drug: Heparin sodium lock solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant catheter dysfunction
Time from randomization to the first clinically significant catheter dysfunction event, defined as either: (1) use of intraluminal thrombolytic therapy (alteplase/rt-PA), or (2) definitive catheter loss (permanent catheter removal or over-the-wire exchange) due to catheter dysfunction. The following are not considered events for the primary outcome: line reversal, flushing with crystalloid, postural changes, or radiography with subsequent manipulation unless they are followed by thrombolytic use or definitive catheter loss.
Measured: From randomization (T0) up to 24 months
Secondary outcomes (6)
Minor catheter dysfunction requiring simple maneuvers.
Time from randomization to the first episode of catheter dysfunction managed with simple maneuvers only, defined as any of the following performed to restore adequate dialysis without thrombolytic therapy or catheter exchange: line reversal, flushing/permeabilization with crystalloid, patient repositioning, or radiography followed by catheter manipulation/repositioning. Episodes that subsequently require alteplase/rt-PA or definitive catheter loss are counted as primary outcome events (and are not classified as 'minor').
Measured: From randomization (T0) up to 24 months
Rescue procedures for catheter dysfunction (number of procedures per participant)
Total number of protocol-defined rescue procedures performed for catheter dysfunction per participant during follow-up (line reversal, flushing/permeabilization with crystalloid, patient repositioning, or radiography followed by catheter manipulation/repositioning)
Measured: Up to 24 months
Catheter-related infection rate (per 1,000 catheter-days)
Rate of catheter-related infection events defined using CDC criteria, expressed as events per 1,000 catheter-days during follow-up. Catheter-days are calculated from randomization until catheter removal/exchange or censoring.
Measured: Up to 24 months
Major bleeding (ISTH)
Occurrence of major bleeding events defined according to ISTH criteria during follow-up.
Measured: Up to 24 months
Clinically relevant non-major bleeding (ISTH)
Occurrence of clinically relevant non-major bleeding events defined according to ISTH criteria during follow-up.
Measured: Up to 24 months
All-cause mortality
Death from any cause during follow-up.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Access FailureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are individually randomized in a 1:1 ratio to one of two parallel groups and remain in the assigned group throughout follow-up (no crossover). Randomization is generated a priori using permuted blocks with concealed allocation. Follow-up is conducted at each hemodialysis session, with administrative censoring at 24 months or earlier upon permanent catheter removal/exchange, loss of catheter function requiring definitive intervention, kidney transplant, modality change, withdrawal, or death. The trial uses a PROBE approach: open-label clinical management with blinded endpoint adjudication by an independent committee.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Alberto Gomez Fregoso, Hospital Civil de Guadalajara
- Investigators
- Juan A Gomez Fregoso, Nephrologist, Principal investigator, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" (Servicio de Nefrología)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404345
- Sponsor's protocol ID
- APICATH-HD-01
- Acronym
- APICATH-HD
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in publications will be shared upon reasonable request.