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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
First received
Last updated
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
Health authority
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.

Study Design


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
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