New implant could speed up dialysis fistula maturation

NCT ID NCT05425056

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This phase 3 trial tests a sirolimus-releasing collagen implant placed around a new dialysis fistula during surgery. The goal is to help the fistula mature faster so it can be used for dialysis. The study involves 136 people aged 65+ with kidney failure who are new to hemodialysis. Results will compare fistula maturation and long-term usability between those who get the implant and those who don't.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
sirolimus-eluting collagen implant (Sirogen)
What this could lead to
If it works, this implant could help dialysis patients get a working fistula sooner and reduce complications.
What could go wrong
This is a small, early-phase 3 trial with only 136 participants. The implant may not improve fistula outcomes and carries risks like infection or allergic reaction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

Contacts and locations

Locations

  • American Access Care of Miami

    Miami, Florida, 33156, United States

  • Arteries & Veins

    El Paso, Texas, 79912, United States

  • Atrium Health

    Charlotte, North Carolina, 28204, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Barts Health NHS Trust of Royal London Hospital

    London, United Kingdom

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Houston Methodist

    Sugar Land, Texas, 77479, United States

  • James Eric Gardner, MD PC

    Memphis, Tennessee, 38115, United States

  • Lundquist Institute for Biomedical Innovation

    Torrance, California, 90502, United States

  • MedStar Cardiovascular Research Network at MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • NHS Greater Glasgow and Clyde

    Glasgow, United Kingdom

  • Sentara Norfolk General Hospital/Sentara Health Research Center

    Norfolk, Virginia, 23507, United States

  • St George's University Hospitals NHS Foundation Trust

    London, United Kingdom

  • St Helier Hospital

    Carshalton, SM5 1AA, United Kingdom

  • Surgical Specialists of Charlotte

    Charlotte, North Carolina, 28207, United States

  • The Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • The Regional Medical Center/Dialysis Access Institute

    Orangeburg, South Carolina, 29118, United States

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, United Kingdom

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • Veterans Affairs San Diego Health Center

    San Diego, California, 92161, United States

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