Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
FGK Clinical Research Sp. zo.o.
FGK Clinical Research GmbH
Information provided by (Responsible Party):
Humacyte, Inc.
ClinicalTrials.gov Identifier:
NCT01744418
First received: December 5, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.

The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.


Condition Intervention
End-stage Renal Disease
Kidney Failure, Chronic
Device: HAVG graft implantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte's Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Humacyte, Inc.:

Primary Outcome Measures:
  • HAVG safety & tolerability [ Time Frame: At each visit within first 6 months after HAVG implantation. ] [ Designated as safety issue: Yes ]
    The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be tabulated by visit and overall.

  • HAVG patency rate [ Time Frame: At 6 months after HAVG implantation. ] [ Designated as safety issue: No ]
    Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG.


Secondary Outcome Measures:
  • PRA response [ Time Frame: At screening, day 15, 29, 57 and week 12, 26 ] [ Designated as safety issue: Yes ]
    Assess changes in the PRA response over the 6 months after graft implantation.

  • IgG antibodies [ Time Frame: At screening, day 15, 29, 57 and week 12, 26 ] [ Designated as safety issue: Yes ]
    Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG.

  • Patency maintenance/restoration [ Time Frame: At each visit except screening. ] [ Designated as safety issue: No ]
    Determine the rates of interventions needed to maintain / restore patency in the graft.

  • HAVG patency rates [ Time Frame: At 12, 18, 24 months after HAVG implantation. ] [ Designated as safety issue: No ]
    Patency rates (primary, primary assisted and secondary) at 12, 18 and 24 months.


Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HAVG graft
HAVG graft implantation to study participants.
Device: HAVG graft implantation
Patients will be implanted with a Human Acellular Vascular Graft (HAVG) in the forearm or upper arm (arterial anastomosis to the radial or brachial artery, venous anastomosis to either the brachial, cephalic or very central basilica vein) using standard vascular surgical techniques. The graft will be placed in a straight or curved configuration in the first 10 patients. Loop grafts may be permitted in subsequent patients subject to acceptable graft performance at the interim safety review. Placing the graft across the elbow will be avoided.
Other Name: Human Acellular Vascular Graft

Detailed Description:

The HAVG is a sterile, non-pyrogenic, acellular tubular graft composed of human collagens and other natural extra-cellular matrix proteins. Upon implantation, it is anticipated (based on pre-clinical studies) that the collagen-based matrix comprising the graft will be infiltrated with host cells and re-modeled by the host. This will result in a vascular structure more similar to the histological composition of the native vascular tissue that may improve graft longevity and be less likely to become infected.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with end stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula and therefore need placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
  • Patients between 18 and 75 years old, inclusive
  • Suitable anatomy for implantation of straight forearm grafts or curved upper arm grafts (arterial anastomosis to radial or brachial artery, venous anastomosis to either brachial cephalic or very central basilica vein)
  • Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 prior to Day 1
  • Other hematological and biochemical parameters within a range consistent with ESRD and acceptable for the administration of general anesthesia prior to Day 1
  • Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, and alkaline phosphatase ≤2x upper limit of normal or INR ≤ 1.5 prior to Day 1.
  • Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
  • Able and willing to give informed consent
  • Life expectancy of at least 1 year

Exclusion Criteria:

  • History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
  • History or evidence of severe peripheral vascular disease in the upper limbs
  • Known or suspected central vein obstruction on the side of planned graft implantation
  • Stroke within six (6) months of study entry (Day 1)
  • Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
  • Treatment with vitamin K-antagonists or direct thrombin inhibitors within the previous month to study entry (Day 1)
  • All patients (including both female patients of childbearing potential and male patients with childbearing potential partners) who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), e.g. implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
  • Active diagnosis of cancer within the previous year
  • Immunodeficiency including AIDS / HIV
  • Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
  • Bleeding diathesis
  • Active autoimmune disease
  • Previous PTFE graft in the operative limb unless the HAVG can be placed more proximally than the previous failed graft
  • More than 1 failed PTFE graft in the operative limb
  • Active local or systemic infection (WBC > 15,000/mm3)
  • Patients receiving a forearm graft with which crosses the elbow
  • Patients receiving an upper arm graft with arterial anastomosis to the axillary artery or venous anastomosis to the axillary vein
  • Patients receiving a lower extremity AV access
  • Known serious allergy to aspirin or penicillin
  • Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAVG
  • Previous enrollment in this study
  • Employees of the sponsor or patients who are employees or relatives of the investigator
  • PRA > 20% (first 10 patients only)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744418

Locations
Poland
Department of Vascular Surgery and Angiology at the Medical University Lublin
Lublin, Poland, 20-081
Independent Public Central Clinical Hospital in Warsaw; Department of General, Vascular and Transplant Surgery
Warsaw, Poland, 02-097
Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery
Wroclaw, Poland, 51-124
Sponsors and Collaborators
Humacyte, Inc.
FGK Clinical Research Sp. zo.o.
FGK Clinical Research GmbH
Investigators
Study Director: Alison J. Pilgrim, BM BCh Phil Humacyte, Inc.
  More Information

No publications provided

Responsible Party: Humacyte, Inc.
ClinicalTrials.gov Identifier: NCT01744418     History of Changes
Other Study ID Numbers: CLN-PRO-V001
Study First Received: December 5, 2012
Last Updated: July 7, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by Humacyte, Inc.:
ESRD
HEMODIALYSIS
CHRONIC RENAL INSUFFICIENCY
Renal Dialysis
Hemodiafiltration
Blood Vessel Prosthesis
Tissue-Engineered Vascular Graft
Vascular Prosthesis Implantation

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on August 19, 2014