New implant could help dialysis patients avoid fistula failures
NCT ID NCT05425056
First seen Nov 01, 2025 · Last updated Jun 19, 2026 · Updated 28 times
Summary
This phase 3 trial tested a sirolimus-coated collagen implant placed around a new dialysis fistula during surgery. The goal was to see if it helps the fistula mature faster and stay usable for dialysis. 136 people with kidney failure on hemodialysis took part. The implant is a one-time treatment meant to prevent complications.
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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American Access Care of Miami
Miami, Florida, 33156, United States
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Arteries & Veins
El Paso, Texas, 79912, United States
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Atrium Health
Charlotte, North Carolina, 28204, United States
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Augusta University
Augusta, Georgia, 30912, United States
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Barts Health NHS Trust of Royal London Hospital
London, United Kingdom
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Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
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Houston Methodist
Houston, Texas, 77030, United States
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Houston Methodist
Sugar Land, Texas, 77479, United States
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James Eric Gardner, MD PC
Memphis, Tennessee, 38115, United States
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Lundquist Institute for Biomedical Innovation
Torrance, California, 90502, United States
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MedStar Cardiovascular Research Network at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
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Sentara Norfolk General Hospital/Sentara Health Research Center
Norfolk, Virginia, 23507, United States
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St George's University Hospitals NHS Foundation Trust
London, United Kingdom
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St Helier Hospital
Carshalton, SM5 1AA, United Kingdom
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Surgical Specialists of Charlotte
Charlotte, North Carolina, 28207, United States
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The Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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The Regional Medical Center/Dialysis Access Institute
Orangeburg, South Carolina, 29118, United States
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University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
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University of Louisville
Louisville, Kentucky, 40202, United States
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Veterans Affairs San Diego Health Center
San Diego, California, 92161, United States
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
sirolimus (drug-coated collagen implant placed around the fistula during surgery)
What this could lead to
If it works, this implant could help dialysis fistulas mature faster and stay usable longer, reducing complications for people with kidney failure.
What could go wrong
This is a completed phase 3 trial with 136 participants, so results are limited. The implant may not improve fistula outcomes, and there is a risk of allergic reaction to sirolimus or collagen.
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.