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Human Acellular Vessel (HAV) for Vascular Access

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Vascular Access+3 MoreHuman Acellular Vessel (HAV) - Biological
Eligibility
18+
All Sexes
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Study Summary

This trial is comparing the two most common types of hemodialysis access: Human Acellular Vessel (HAV) and arteriovenous fistula (AVF).

Eligible Conditions
  • Vascular Access
  • Kidney Failure
  • Hemodialysis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Informed Assent Discussion
1
RIC twice per day
2
Sirolimus

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: 12, 24, and 60 months post SA creation

Month 12
Incidence rate of HD access related interventions over the period from SA creation until SA abandonment or 12 months post SA creation
Incidence rate of infections related to any HD access in situ over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment.
Number of days with DC in situ "catheter contact time" over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment
Proportion of HD sessions completed via DC (1 or 2 lines) over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment.
Proportion of subjects with secondary patency of SA at 12 months post SA creation.
Month 60
Frequency and severity of AEs.
Histopathological remodeling of HAV and AVF - based on histological examination of SA samples explanted for clinical reasons
Incidence rate of HD access-related infections over the period from SA creation until SA abandonment.
Incidence rate of SA site infections (CDC definition) over the period from SA creation until SA abandonment.
Incidence rate of clinically significant aneurysm or pseudoaneurysm over the period from SA creation until SA abandonment
Time to loss of primary unassisted patency
Time to loss of secondary patency (abandonment).
Month 6
Incidence rate of HD access-related interventions over the period from SA creation until SA abandonment or the conclusion of the suitability ascertainment period (6 months).
Proportion of subjects with functional patency at 6 months post study access (SA) creation
Proportion of subjects with unassisted functional patency at 6 months post SA creation.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Informed Assent Discussion
2
RIC twice per day
3
Sirolimus

Trial Design

2 Treatment Groups

Arteriovenous fistula (AVF)
1 of 2
Human Acellular Vessel (HAV)
1 of 2

Active Control

Experimental Treatment

240 Total Participants · 2 Treatment Groups

Primary Treatment: Human Acellular Vessel (HAV) · No Placebo Group · Phase 3

Human Acellular Vessel (HAV)
Biological
Experimental Group · 1 Intervention: Human Acellular Vessel (HAV) · Intervention Types: Biological
Arteriovenous fistula (AVF)
Procedure
ActiveComparator Group · 1 Intervention: Arteriovenous fistula (AVF) · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12, 24, and 60 months post sa creation

Who is running the clinical trial?

California Institute for Regenerative Medicine (CIRM)OTHER
59 Previous Clinical Trials
3,020 Total Patients Enrolled
1 Trials studying Vascular Access
355 Patients Enrolled for Vascular Access
Humacyte, Inc.Lead Sponsor
8 Previous Clinical Trials
580 Total Patients Enrolled
2 Trials studying Vascular Access
385 Patients Enrolled for Vascular Access
CTI Clinical Trial and Consulting ServicesOTHER
33 Previous Clinical Trials
3,324 Total Patients Enrolled
1 Trials studying Vascular Access
355 Patients Enrolled for Vascular Access
Kiernan DeAngelis, MDStudy DirectorHumacyte, Inc.
6 Previous Clinical Trials
560 Total Patients Enrolled
2 Trials studying Vascular Access
385 Patients Enrolled for Vascular Access
Lynda Szczech, MD, MSCEStudy DirectorHumacyte, Inc.
6 Previous Clinical Trials
560 Total Patients Enrolled
2 Trials studying Vascular Access
385 Patients Enrolled for Vascular Access
Shamik Parikh, MDStudy DirectorHumacyte, Inc.
4 Previous Clinical Trials
515 Total Patients Enrolled
1 Trials studying Vascular Access
355 Patients Enrolled for Vascular Access

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who are at least 18 years old will be screened.
The text describes the anatomy of the forearm and arm that is suitable for creating an arteriovenous fistula (AVF) and for implanting a hemodialysis access device (HAV).
The patient has a hemoglobin level of at least 8 grams per deciliter and a platelet count of at least 100,000 per cubic millimeter.
Someone who is post-menopausal, surgically sterile, or has had a hysterectomy for at least one month prior to screening is considered to be of non-childbearing potential.
All subjects in the study received HD via DC for at least 6 months before study entry
Individuals who plan to undergo HD at a dialysis unit that is a part of a participating dialysis provider for at least the first 6 months after their self-administered hemodialysis (SA) creation.
The International Normalized Ratio (INR) is less than or equal to 1.5.
Hormonal contraception methods that can be used orally, injected or implanted.
The placement of an intrauterine device or intrauterine system is a medical procedure in which a device or system is placed in the uterus.
Barrier methods of contraception include condoms and occlusive caps (diaphragms or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.
References

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