Low-Dose Apixaban Added to Standard Heparin Lock Versus Heparin Lock Alone to Prevent Tunneled Hemodialysis Catheters Dysfunction (APICATH-HD)

NCT07404345 | Not Yet Recruiting Phase 4

• 1 other identifier: APICATH-HD-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hemodialysis Access Failure; Kidney Disease, End-Stage; Hemodialysis Catheter

Keywords

Hemodialysis; Tunneled central venous catheter; Catheter dysfunction; Catheter Failure; Catheter thrombosis; Apixaban; Heparin lock; End-stage kidney disease; Vascular access; Anticoagulation; PROBE trial

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization (T0) up to 24 months

Secondary Outcomes (6)

• Minor catheter dysfunction requiring simple maneuvers.

  From randomization (T0) up to 24 months

• Rescue procedures for catheter dysfunction (number of procedures per participant)

  Up to 24 months

• Catheter-related infection rate (per 1,000 catheter-days)

  Up to 24 months

• Major bleeding (ISTH)

  Up to 24 months

• Clinically relevant non-major bleeding (ISTH)

  Up to 24 months

Study Arms (2)

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.

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.

Drug: Apixaban; Drug: Heparin sodium lock solution

Interventions

Apixaban DRUG

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.

Apixaban

Heparin sodium lock solution DRUG

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.

Apixaban; Heparin sodium lock solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44200, Mexico

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

apixaban

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan A Gomez Fregoso, Nephrologist

  Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" (Servicio de Nefrología)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenifer M Langarica Lopez, Nephrology fellow

CONTACT

+523221127583; jeni.langarica@gmail.com

Manuel Arizaga Napoles, Nephrologist

CONTACT

+523317476634; man.arizaga.napoles@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a randomized, open-label, parallel-group trial. Participants and treating clinicians are aware of treatment allocation, as no placebo is used. To minimize assessment bias, all primary and secondary outcomes related to catheter dysfunction and catheter-related infections are adjudicated by an independent committee blinded to treatment allocation. Data provided to the adjudication committee are de-identified and coded to conceal group assignment. This approach is consistent with a PROBE (Prospective, Randomized, Open-label, Blinded Endpoint) study design
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after primary publication and ending 5 years thereafter
• Access Criteria: Requests will be reviewed by the study steering committee. Data will be shared with qualified researchers for methodologically sound proposals, after approval and execution of a data use agreement. Only de-identified data will be provided; no direct identifiers will be shared

Locations

ME (1)