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Safety and efficacy of locally administered APAC, heparin sodium and sodium chloride to promote arteriovenous fistula maturation in patients with end‑stage kidney disease

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

People with End stage kidney disease often need a special connection between an artery and a vein, called an arteriovenous fistula, so that blood can be cleaned during hemodialysis. In this study a new medication named APAC, which works as both an antiplatelet (prevents small blood cells from sticking together) and an anticoagulant (prevents larger clots from forming), is applied directly to the surgical site when the fistula is created.

The purpose of the trial is to see whether the local use of APAC is safe and helps the fistula become ready for dialysis without extra procedures. After the fistula surgery, participants receive either the study medication or the usual care (a simple saline solution or heparin) applied to the same spot. They are then monitored for about six weeks with clinic visits, brief examinations of the arm, and a painless ultrasound scan that looks at the size of the vein and the flow of blood.

During the follow‑up, doctors look for any problems such as swelling, redness, pain, bleeding, infection, or signs that the fistula is not working well. They also check whether the fistula is mature enough to be used for dialysis by feeling for a vibration (thrill) and listening for a sound (bruit) and by confirming the ultrasound results. Participants may be asked to rate their pain and complete a short questionnaire about their overall well‑being.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment and enrollment

    After you agree to join the study, basic health information is recorded, including your kidney condition and any other medicines you take.

    A brief physical exam and a blood sample may be taken to confirm eligibility.

  2. Step 2

    Random assignment and arteriovenous fistula surgery

    You will be assigned by chance to receive either the test drug apac or a standard treatment such as sodium chloride or heparin sodium. this assignment is kept hidden from you (blinded).

    The surgeon creates an arteriovenous fistula (avf), which is a small connection between an artery and a vein that will later be used for hemodialysis.

  3. Step 3

    Local administration of study medication

    Immediately after the fistula is created, the study medication is applied directly to the surgical site.

    If you are in the test group, a single dose of 3.75 mg of apac is injected or infused at the site.

    If you are in a comparator group, you receive either 50 iu of sodium chloride or 50 iu of heparin sodium, also applied locally.

    The medication is given only once, at the time of surgery.

  4. Step 4

    Immediate postoperative monitoring

    After surgery, you will stay in the hospital for routine observation.

    Staff will watch for any signs of bleeding, swelling, redness, pain, or fever at the fistula site.

    Pain will be recorded using a simple 0‑to‑10 visual analogue pain scale.

  5. Step 5

    Day 42 follow‑up visit

    Approximately forty‑two days after surgery, you return for a comprehensive check.

    The doctor will ask about any side effects or problems you have experienced.

    A duplex ultrasound exam is performed to measure the size of the vein and the blood flow in the artery; successful maturation is defined as a vein diameter of at least 4 mm in most locations and arterial flow of at least 500 ml/min.

    Pain level, any local swelling, redness, bruising, or bleeding are recorded again.

    Blood tests may be done to look for signs of infection or inflammation.

  6. Step 6

    Day 90 and day 180 additional assessments

    You will be asked to attend further visits at about three months (day 90) and six months (day 180) after surgery.

    During these visits the usability of the fistula for hemodialysis is evaluated; if the fistula is being used, the staff checks whether two needles can be placed effectively.

    Additional duplex ultrasound examinations may be performed to assess any changes in the fistula.

    You will complete a short questionnaire about your overall quality of life and how the fistula affects daily activities.

  7. Step 7

    Study completion

    After the final visit, all study data are collected and the trial is closed for you.

    No further study medication is given, and you continue routine care for your kidney disease as advised by your regular health team.

Who can join the trial?

19 criteria

  • Be at least 18 years old, regardless of gender.
  • Not be taking part in any other investigational clinical trial while this study is running.
  • Be able to understand the study instructions, follow them, and talk with the study staff.
  • Sign a written informed consent form that has been approved by an Ethics Committee.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at screening and agree to use a highly effective contraception method (a birth‑control method that fails less than 1% of the time per year) from screening until 42 days after the AVF surgery.
  • If you are a man, you must agree to use a condom and ensure that any partner who could become pregnant also uses a highly effective contraception method for at least 2 weeks after the study drug is given.
  • Men must not donate sperm from the time of screening until 2 weeks after receiving the study drug.
  • Have a life expectancy of at least 6 months.
  • Have a diagnosis of End Stage Kidney Disease (ESKD) with an estimated glomerular filtration rate (eGFR) lower than 15 mL/min, indicating very poor kidney function.
  • Plan to have a new wrist‑area arteriovenous fistula (AVF) created using the cephalic vein and the radial artery (the surgeon will join these vessels near the wrist, not in the “snuff box”).
  • Expect to need renal replacement therapy (RRT)—such as dialysis—within the next 6 months, or already be using a central venous catheter on the opposite side of the planned AVF within the past 6 months.
  • Undergo a pre‑operative ultrasound vein and arterial mapping (an imaging test that checks the size and condition of the blood vessels) that shows the anatomy is suitable for AVF creation, as confirmed by the surgeon.
  • Have a vessel size (luminal diameter) of at least 2 mm for both the distal radial artery and the cephalic vein, and the radial artery must be compressible when pressure is applied with the ultrasound probe.
  • Have at least one factor that can make AVF maturation harder, such as:
    • Small artery (<2.5 mm) or vein (<3 mm) at the wrist, or small artery (<4 mm) or vein (<4 mm) at the elbow.
    • Calcified (hard) artery.
    • Vein located more than 5 mm below the skin.
    • Vein length less than 6 cm for needle insertion.
    • Age over 65 years, female gender, diabetes, peripheral arterial disease, other blood‑vessel disease, or body mass index (BMI) over 29 kg/m².
    • Agree not to receive far‑infrared therapy (a treatment that uses specific light wavelengths to heat tissues) during the study.

Who cannot join the trial?

11 criteria

  • You cannot join if you are allergic to heparin (a medicine that thins the blood), have had heparin‑induced thrombocytopenia (HIT) (a drop in platelets caused by heparin), or are allergic to protamine sulphate (the drug used to reverse heparin).
  • You cannot join if you are scheduled to receive a kidney from a living donor within the next 60 days.
  • You cannot join if you already have an arteriovenous fistula (AVF) on the same arm where the new AVF is planned.
  • You cannot join if you have an active cancer (blood‑related or solid tumor) or have been treated for cancer in the past year, except for skin cancers that have been completely removed.
  • You cannot join if you are currently on peritoneal dialysis (a type of dialysis that uses the lining of the abdomen) and plan to switch to hemodialysis (dialysis that uses a machine).
  • You cannot join if you have any serious medical problem that could affect the study results, such as unstable heart disease, a mechanical heart valve that needs a blood‑thinner called a vitamin K antagonist, irregular heartbeat (atrial fibrillation), a clotting event in the past three months, a current infection, an active autoimmune disease (like antiphospholipid syndrome), or any widespread inflammatory disease.
  • You cannot join if you have taken more than one blood‑thinner or clot‑preventing medicine (antithrombotic) in the 10 days before signing the consent form.
  • You cannot join if you have used any experimental medicine in the past 30 days or any experimental antibody treatment in the past 90 days.
  • You cannot join if you have anemia (low hemoglobin level of 90 g/L or less) or significant problems with your platelet count or white blood cell count.
  • You cannot join if your Body Mass Index (BMI) is 40 kg/m² or higher (considered severe obesity).
  • You cannot join if your doctor plans to move a vein or make it more superficial (called vein transposition or superficialization) to make dialysis work.
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Investigated drugs

  • Sodium chloride

    is a sterile salt solution that is applied locally at the surgery site. In this trial it is used as a comparison treatment to see how the new therapy works against a simple, inert solution that does not have any active drug effect.

  • Heparin sodium

    is a standard blood‑thinning medication given by injection at the surgical site. It helps prevent clots from forming after the fistula surgery. In the study it serves as another control to compare the new treatment against an established anticoagulant that is already used in clinical practice.

  • APAP

    is an experimental medication that combines unfractionated heparin from pigs with human serum albumin, creating a heparin‑proteoglycan mimetic. It is designed to act both as an antiplatelet and an anticoagulant when applied locally to the fistula surgery site. The trial is testing whether APAP can improve the maturation of the new vascular access for dialysis without causing safety problems.

What is already known about the treatment

  • Sodium Chloride

    This medication is applied locally as a sterile saline solution, typically used to rinse or irrigate tissues during surgery. It is an established, widely used electrolyte that balances fluid and salt levels in the body. Its main use is to clean wounds or serve as a control fluid in medical procedures. It belongs to the class of isotonic saline solutions.

  • Heparin Sodium

    This drug is given locally as a clear solution for injection, with a dose measured in international units. Heparin sodium is an approved anticoagulant that has been used for many decades to stop blood from clotting during surgeries and dialysis procedures. It works by attaching to a protein called antithrombin, which then blocks several clotting factors in the blood. It is classified as an anticoagulant and antithrombotic agent.

  • APAC

    APAC is administered locally by injection or infusion directly at the site of arteriovenous fistula surgery, using a small milligram dose. It is an experimental drug currently being studied in clinical trials for patients with end‑stage kidney disease. The product is designed to help the new blood vessel mature by mimicking natural molecules that prevent clots and reduce platelet sticking, combining heparin with human serum albumin. It is classified as an antithrombotic heparin proteoglycan mimetic.

Investigated diseases

End-stage renal disease - It is the final phase of chronic kidney disease where the kidneys can no longer filter waste effectively. Kidney function declines gradually over months to years until the glomerular filtration rate falls below 15 mL/min. As filtration worsens, fluid and waste accumulate in the body, leading to the need for dialysis or transplantation. The condition usually follows long‑term hypertension, diabetes, or other kidney‑damaging illnesses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526207-30-00Protocol codeAPLA-AVF-CS01Estimated enrolment90 patientsSponsorAplagon Oy

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