Clinical trial NCT02644941: Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Failure
End Stage Renal Disease
Hemodialysis
Vascular Access
Lead sponsor: Humacyte, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CTI Clinical Trial and Consulting Services
name: California Institute for Regenerative Medicine (CIRM)
First posted: 2016-01-01
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Participants who consented were randomized to the HAV treatment arm of one of the two commercially available comparators.

Eligibility criteria: Inclusion Criteria:

* Subjects with ESRD who need placement of an AV graft in the arm.
* Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.
* 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).
* Female subjects must be either:

  * Of non-childbearing potential Or
  * Must agree to use at least one form of birth control methods for the duration of the study.
* 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 stenosis or conduit occlusion on the ipsilateral side of planned implantation, unless the stenosis is corrected prior to study conduit implantation.
* Treatment with any investigational drug or device within 60 days prior to study entry (Day 0).
* Cancer that is actively being treated with a cytotoxic agent.
* Documented hyper-coagulable state.
* Bleeding diathesis.
* Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
* High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
* Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
* The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
* tacrolimus or FK506 \[Prograf\]
* mycophenolate mofetil \[Cellcept\],
* cyclosporine \[Sandimmune or Gengraf\] i-Sirolimus administered systemically (Sirolimus in drug eluting stents is NOT an exclusion)
* Anticipated renal transplant within 6 months.
* Venous outflow from study conduit cannot be placed more centrally than the venous outflow of any previous failed access in that extremity.
* 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.

Primary outcomes:
measure: Number of Participants With Loss of Secondary Patency
timeFrame: 12 months post-implantation
measure: Number of Participants With Loss of Secondary Patency
timeFrame: 18 months post-implantation
measure: Number of Participants With Loss of Secondary Patency
timeFrame: 24 months post-implantation
Secondary outcomes:
measure: Number of Participants With Loss of Primary Patency
timeFrame: 12 months post-implantation
measure: Number of Participants With Loss of Primary Patency
timeFrame: 18 months post-implantation
measure: Number of Participants With Loss of Primary Patency
timeFrame: 24 months post-implantation
measure: Number of Participants With Loss of Primary Patency
timeFrame: 60 months post-implantation
measure: Study Conduit Abandonment
timeFrame: 24 months post-implantation
measure: Study Conduit Abandonment
timeFrame: 60 months post-implantation
measure: Rate of Adjudicated Study Conduit Access Related Infections
timeFrame: 24 months post-implantation
measure: Access-related Infections
timeFrame: 60 months post-implantation
measure: Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency
timeFrame: 24 months post-implantation
measure: Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters)
timeFrame: 60 months post-implantation
measure: Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters)
timeFrame: 60 months post-implantation
measure: Thrombosis of Study Access That Required Intervention
timeFrame: 24 months post-implantation
measure: Thrombosis of Study Access That Required Intervention
timeFrame: 60 months post-implantation
measure: Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects)
timeFrame: 2 to 18 Months post-implantation
measure: Severity of Adverse Events
timeFrame: 24 months post-implantation
measure: Number of Participants With at Least One Adverse Event
timeFrame: 24 months post-implantation
measure: True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)
timeFrame: 24 months post-implantation
measure: True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)
timeFrame: 60 months post-implantation
measure: Pseudoaneurysm Formation
timeFrame: 24 months post-implantation
measure: Pseudoaneurysm Formation
timeFrame: 60 months post-implantation
measure: Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
timeFrame: 24 months post-implantation
measure: Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
timeFrame: 60 months post-implantation
measure: Anastomotic Bleeding or Rupture
timeFrame: 24 months post-implantation
measure: Anastomotic Bleeding or Rupture
timeFrame: 60 months post-implantation
measure: Calculated Panel Reactive Antibody More Than 20% Change From Baseline
timeFrame: 18 months post-implantation
measure: Calculated Panel Reactive Antibody More Than 20% Change From Baseline
timeFrame: 24 months post-implantation
measure: Mean Inner Diameter of Conduit (Millimeter)
timeFrame: 12 months post-implantation
measure: Mean Inner Diameter of Conduit (Millimeter)
timeFrame: 24 months post-implantation
measure: Mean Inner Diameter of Conduit (Millimeter)
timeFrame: 60 months post-implantation
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Kidney Disease and Hypertension Center (AKDHC)
state: Arizona
city: Tucson
country: United States
facility: Carondelet St. Mary's Hospital
state: Arizona
city: Fresno
country: United States
facility: Ladenheim Dialysis Access Center
state: California
city: Fresno
country: United States
facility: General Surgery and Vascular Access
state: California
city: Irvine
country: United States
facility: University of California Irvine (UCI) Medical Center
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Mather
country: United States
facility: VA Sacramento Medical Center
state: California
city: San Diego
country: United States
facility: Balboa Nephrology
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Alsip
country: United States
facility: Southwest Vascular Access Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Flint
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: Greenwood
country: United States
facility: Greenwood Leflore Hospital
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Newark
country: United States
facility: Rutgers-New Jersey Medical School
state: New Jersey
city: Westfield
country: United States
facility: The Cardiovascular Care Group
state: New Jersey
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Portland
country: United States
facility: Kaiser Permanente
state: Oregon
city: Orangeburg
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Erlangen
country: Germany
facility: Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum
state: Bayern
city: Frankfurt/Main
country: Germany
facility: Universitätsklinikum Frankfurt Klinik für Gefäß- und Endovascular-Chirurgie
state: Hessen
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
state: Tel-Aviv
city: Hadera
country: Israel
facility: Hillel Jaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Sharee Zedek Medical Center
city: Tzrifin
country: Israel
facility: Yitzhak Shamir Medical Center - Assaf Harofeh
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
city: Warszawa
country: Poland
facility: Samodzielny Publiczyn Centralny Szpital Klinziczny w Warszawie - Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
city: Wroclaw
country: Poland
facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu
city: Porto
country: Portugal
facility: Grupo de Estudos Vasculares
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
state: East Midlands/ Leicestershire
city: London
country: United Kingdom
facility: Guy´s Hospital, Kings´College London
state: Greater London
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: West Midlands
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital Glasgow
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
Study officials:
affiliation: Humacyte, Inc.
name: Shamik Parikh, MD
role: STUDY_DIRECTOR
References: