A Phase II, randomized, blinded, dose selection study to assess safety and preliminary efficacy of antithrombotic heparin proteoglycan mimetic APAC (antiplatelet, anticoagulant) administered locally to the site of arterio-venous fistula (AVF) surgery to facilitate maturation of hemodialysis (HD) vascular access in patients with end stage kidney disease (ESKD) (MATURATION)
People with advanced kidney disease often need haemodialysis to clean their blood. To make this possible, surgeons create an arteriovenous fistula (often called an AVF or fistula) by joining an artery to a vein in the arm. Before it can be used, the fistula must 'mature'—meaning the vein needs to heal, thicken, and widen to handle dialysis needles. Unfortunately, many fistulas do not mature properly or become blocked by blood clots. This Phase II clinical trial tests an experimental medicine called APAC, which is designed to prevent clots and calm inflammation. During surgery, APAC, standard heparin, or a harmless salt-water solution is applied directly to the blood vessels. Researchers will track side effects, wound healing, and use ultrasound scans to see if APAC helps the fistula develop successfully for regular dialysis.
At a glance
What is this study about?
When your kidneys can no longer filter waste from your blood, you may need a treatment called haemodialysis. To carry out dialysis easily and safely, a surgeon creates a connection between an artery and a vein, usually in your forearm. This connection is called an arteriovenous fistula (AVF). Over a few weeks, the extra blood rushing into the vein should cause it to grow wider and stronger. Doctors call this process 'maturation'.
However, getting a fistula to work well can be challenging. In many patients, blood clots form, or the vein walls become narrow and stiff. If a fistula fails to mature, a person may need further operations or temporary plastic tubes (catheters) placed in their neck, which carry a higher risk of infection.
This trial is investigating a new medicine called APAC. Unlike typical blood thinners that travel throughout your entire body and raise your risk of bleeding everywhere, APAC is applied just once, directly to the surgical area inside the arm. Researchers hope this local treatment will stop clots and encourage smooth healing without causing dangerous bleeding elsewhere.
By taking part, patients help doctors find the safest and most effective dose of APAC. If successful, this treatment could help more kidney patients achieve working fistulas on the first try, reducing the need for repeat hospital procedures.
Key takeaways
- Tests a new medicine, APAC, applied locally to the arm during fistula surgery.
- Aims to help veins widen and carry enough blood for successful haemodialysis.
- Open to adults aged 18+ with kidney failure who need a new arm fistula.
- Involves regular follow-up visits, wound checks, and painless ultrasound scans.
- Voluntary participation that does not change your right to standard NHS care.
Who may be eligible?
This trial is open to adults aged 18 and older who have end-stage kidney disease (kidney failure) and are planning to have surgery to create a new arteriovenous fistula in their arm for haemodialysis.
Both men and women may take part. To be eligible, your surgical team must confirm that your arm blood vessels are suitable for a standard fistula procedure.
You may not be able to join if you have certain active bleeding disorders, severe medical conditions that make surgery unsafe, or known allergies to the study medications. The study team will review your full medical history and perform standard blood tests before confirming if the trial is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with end-stage kidney disease (kidney failure).
- I am scheduled to have surgery to create a new arteriovenous fistula in my arm.
- I do not have an active, uncontrolled bleeding condition.
- I am able and willing to attend follow-up hospital visits for wound checks and ultrasounds.
What does participation involve?
If you take part, your study medicine will be applied inside your arm just once, during your scheduled fistula surgery. You will be randomly assigned to receive either the new medicine (APAC), a standard blood thinner (heparin), or a plain salt-water solution. Neither you nor your surgeon will choose which one you receive.
After your operation, you will attend routine follow-up clinic visits over several weeks. During these checks, the medical team will examine your arm for swelling, bruising, and pain. You will have painless ultrasound scans to measure the size of your vein and the speed of your blood flow. If your fistula is ready, the team will check whether it can be used smoothly for regular dialysis sessions using two needles. In total, participation usually lasts a few months alongside your normal kidney care.
Potential risks and benefits
Locations (3)
- —UnverifiedSweden
- —UnverifiedSpain
- —UnverifiedFinland
Common questions
What is an arteriovenous fistula (AVF)?
An AVF is a surgically created link between an artery and a vein, usually in your arm. It provides a sturdy, high-flow access point for haemodialysis needles.
How is the trial medicine given?
The medicine is placed directly onto the blood vessels in your arm by the surgeon during your fistula operation. You do not need to take daily pills or have extra injections at home.
Will I definitely receive the new drug APAC?
No. This is a randomised trial, meaning a computer randomly selects whether you receive APAC, standard heparin, or a salt-water solution.
Will having ultrasound scans hurt?
No. Ultrasound scans use sound waves and cold gel on your skin. They are completely painless and do not use any radiation.
What happens if my fistula does not work?
Your kidney care team will monitor you closely. If the fistula fails to mature, your doctors will discuss other standard treatment options with you, exactly as they would outside of a trial.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.