Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:

An Assessment of Humacyte's Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison With ePTFE Grafts as Conduits for Hemodialysis (HUMANITY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644941
• Other study ID #: CLN-PRO-V006
• Secondary ID: 2015-003261-28
• Status: Completed
• Phase: Phase 3
• Start date: May 24, 2016
• Est. completion date: September 2023

Study information

• Verified date: February 2024
• Source: Humacyte, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

Description:

This is a Phase 3, prospective, multicenter, multinational, open-label, randomized, two-arm, comparative study. Subjects who sign informed consent would undergo study-specific screening assessments within 35 days from the day of informed consent. On the day of surgery (Day 0), subjects could still be undergoing screening assessments, such as confirmation of inclusion/exclusion criteria, to determine their eligibility before they are randomized in the study. Eligible study subjects will be randomized to receive either a HAV or one of two commercially available ePTFE grafts and followed to 24 months post-implantation at routine study visits regardless of patency status. After 24 months, subjects with a patent study conduit will be followed (while the study conduit remains patent) for up to 5 years (60 months) post implantation at routine study visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with ESRD who are not, or who are no longer, candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the arm (upper- or forearm) to start or maintain hemodialysis therapy.
• Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.
• At least 18 years of age at Screening.
• Suitable anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow).
• Hemoglobin =8 g/dL and platelet count =100,000 cells/mm3 prior to Day 0 (within 35 days).
• Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 35 days).
• Adequate liver function prior to Day 0 (within 35 days), defined as:
• =2x upper limit of normal (ULN) for serum bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase
• =1.5 for International Normalized Ratio (INR) or prothrombin time (PT) = 18 seconds unless the subject is taking an anticoagulant at the time
• Female subjects must be either:
• Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening)
• Or, of childbearing potential, in which case:
• Must have a negative urine pregnancy test at Screening, and
• Must agree to use at least one form of the following birth control methods

for the duration of the study:

• Established use of oral, injectable or implanted hormonal methods of contraception
• Placement of an intrauterine device or intrauterine system
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository
• Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.
• Life expectancy of at least 1 year.

Exclusion Criteria:

• History or evidence of severe peripheral vascular disease in the intended arm for implantation.
• Known or suspected central vein obstruction on the side of planned implantation, unless corrected before study conduit implantation.
• Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
• Cancer that is actively being treated with a cytotoxic agent.
• Documented hyper-coagulable state.
• Bleeding diathesis.
• Active clinically significant autoimmune disease.
• Anticipated renal transplant within 6 months.
• Venous outflow from study conduit cannot be placed more centrally than any previous failed access.
• Active local or systemic infection (white blood cells [WBC] > 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before implantation.
• Known serious allergy to planned antiplatelet agent.
• Pregnant women, or women intending to become pregnant during the course of the trial.
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the study conduit.
• Previous enrollment in this study or any other study with the HAV.
• Employees of Humacyte and employees or relatives of the investigator.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic
• Renal Failure
• Vascular Access

Intervention

Biological:
• Human Acellular Vessel (HAV)
Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

Device:
• ePTFE graft
Surgical implantation of a commercially available ePTFE graft and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

Locations

Country	Name	City	State
Germany	Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum	Erlangen	Bayern
Germany	Universitätsklinikum Frankfurt Klinik für Gefäß- und Endovascular-Chirurgie	Frankfurt/Main	Hessen
Israel	Hillel Jaffe Medical Center	Hadera	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Sharee Zedek Medical Center	Jerusalem
Israel	The Chaim Sheba Medical Center	Ramat Gan	Tel-Aviv
Israel	Assaf Harofeh Medical Center	Tzrifin
Poland	Katedra i Klinika Chirurgii Naczyn i Angiologii Uniwersytetu Medycznego w Lublinie	Lublin	Lubelskie
Poland	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego	Poznan
Poland	Samodzielny Publiczyn Centralny Szpital Klinziczny	Warszawa
Poland	Oddzial Chirurgii Naczyniowej Wojewódzki Szpital Specjalistyczny we Wroclawiu	Wroclaw
Portugal	Hospital da Prelada	Porto
United Kingdom	University Hospital Birmingham QE Hospital	Birmingham	West Midlands
United Kingdom	Queen Elizabeth II Hospital	Glasgow
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Leicester General Hospital	Leicester	East Midlands/ Leicestershire
United Kingdom	Guy´s Hospital, Kings´College London	London	Greater London
United Kingdom	St. George's Hospital	London
United States	Southwest Vascular Access Center	Alsip	Illinois
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Texas Vascular Associates / Baylor	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	University of Maryland Shore Medical Center	Easton	Maryland
United States	Michigan Vascular Center	Flint	Michigan
United States	Ladenheim Dialysis Access Center	Fresno	California
United States	Greenwood Leflore Hospital	Greenwood	Mississippi
United States	University of California, Irvine	Irvine	California
United States	VA Long Beach Healthcare System	Long Beach	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Sacramento VA Medical Center	Mather	California
United States	Rutgers University	Newark	New Jersey
United States	The Regional Medical Center	Orangeburg	South Carolina
United States	Arizona Kidney Disease and Hypertension Center (AKDHC)	Phoenix	Arizona
United States	Kaiser Permanente	Portland	Oregon
United States	Washington University	Saint Louis	Missouri
United States	Balboa Nephrology	San Diego	California
United States	Overlook Medical Center	Summit	New Jersey
United States	Tampa General Hospital	Tampa	Florida
United States	Carondelet St. Mary's Hospital	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Humacyte, Inc.	California Institute for Regenerative Medicine (CIRM), CTI Clinical Trial and Consulting Services

Countries where clinical trial is conducted

United States,  Germany,  Israel,  Poland,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to loss of Secondary Patency from implantation		18 months post-implantation
Secondary	Time to loss of Secondary Patency from implantation		12, 24 & 60 months post-implantation
Secondary	Time to loss of Primary Patency from implantation		12,18, 24, & 60 months post-implantation
Secondary	Access-related infections	Using Dialysis Event Surveillance Manual: CDC; 2013.	12, 18, 24, & 60 months post-implantation
Secondary	Rate of interventions required to achieve/maintain Secondary Patency		12, 18, 24, & 60 months post-implantation
Secondary	Time to loss of Primary Assisted Patency from implantation		12, 18, 24, & 60 months post-implantation
Secondary	Histopathological remodeling of any study conduit	Microscopic examination of explanted conduit for cellular infiltration and extracellular remodeling processes, including neo-synthesis and reorganization of ECM components (descriptive summaries only)	Up to 60 months post-implantation
Secondary	The efficiency of dialysis as assessed by spKt/Vurea (subset of subjects)		12, 18 & 24 months post-implantation
Secondary	Frequency and severity of AEs		12, 18, & 24 months post-implantation
Secondary	True aneurysm formation (conduit lumen diameter >9mm)	Assessed by ultrasound	12, 18, 24, & 60 months post-implantation
Secondary	Pseudoaneurysm formation	Assessed by ultrasound	12, 18, 24, & 60 months post-implantation
Secondary	Study conduit rupture	Assessed by ultrasound	12, 18, 24, & 60 months post-implantation
Secondary	Anastomotic bleeding or rupture	Assessed by ultrasound	12, 18, 24, & 60 months post-implantation