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To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

Testing ATEV vs. AVF for safe dialysis in women with kidney failure.

Recruiting
18 years and older
Female
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is for women with end-stage renal disease (ESRD) needing hemodialysis (HD), a process to clean blood when kidneys fail. It compares two options for dialysis access: the arterio-venous fistula (AVF), a surgically created connection between an artery and a vein, and the arterio-venous graft (ATEV), a synthetic tube connecting the artery and vein. The goal is to see which option works better and is safer by looking at the number of days without needing a catheter and any related infections over 12 months. Women need to be 18 years or older and cannot be pregnant during the study.

  • The study lasts 12 months, with an additional 12 months for some participants.
  • 150 women will participate, with half receiving ATEV and half AVF.
  • Regular follow-ups and tests will be required throughout the study.

Participants need suitable blood vessels for the procedure and must be capable of attending all follow-ups. If you are interested, discuss with your doctor to understand all risks and benefits.

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Study details
    End Stage Renal Disease (ESRD)

NCT05908084

Humacyte, Inc.

31 March 2025

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