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

Comparing two treatments for kidney disease in women needing dialysis.

Recruiting
18 years and older
Female
Phase 3

This study is for women with end-stage renal disease (ESRD) who need hemodialysis (HD). Hemodialysis is a way to clean the blood when the kidneys are not working well. The study checks how long patients can go without a catheter (a tube used for dialysis) and how often they get infections. It compares two methods: HAV (human acellular vessel) and AVF (arterio-venous fistula). An AVF is a special blood vessel created in the arm for HD. Participants will be grouped based on where the AVF or HAV is placed (forearm or upper arm) and how the AVF is made (1-stage or 2-stage). The study lasts 12 months, with a possible extra 12 months if successful. About 150 women will join this study.

  • Study lasts up to 24 months with follow-ups.
  • Participants must be female and 18 or older.
  • Participants can't be pregnant and must use birth control if needed.
Study details
    End Stage Renal Disease (ESRD)

NCT05908084

Humacyte, Inc.

13 December 2024

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