Trial record 1 of 1064 for:    "Kidney Failure, Chronic"
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Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
FGK Clinical Research GmbH
Aptiv Solutions
Information provided by (Responsible Party):
Humacyte, Inc.
ClinicalTrials.gov Identifier:
NCT01840956
First received: April 18, 2013
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 Phase
End-stage Renal Disease
Kidney Failure, Chronic
Biological: HAVG
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study for the Evaluation of 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 graft assessment [ Time Frame: From baseline to week 26 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 assessed by Doppler ultrasound and tabulated.

  • HAVG patency rate [ Time Frame: at Week 26 after HAVG implantation ] [ Designated as safety issue: No ]
    Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG by Doppler ultrasound.

  • Adverse Events [ Time Frame: From baseline to week 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]
    Frequency and severity of AEs of each patient will be documented.

  • HAVG graft interventions [ Time Frame: From baseline to week 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]
    Graft interventions of each patient will be documented.


Secondary Outcome Measures:
  • Change from baseline in Panel Reactive Antibody [ Time Frame: From baseline to day 29, weeks 12 and 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]
    Assess changes in the Panel Reactive Antibody response over the 6 months after graft implantation.

  • Development of IgG antibodies [ Time Frame: From baseline to day 29, weeks 12 and 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]
    Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG.

  • Graft interventions [ Time Frame: At each visit, i.e. day 1, day 4-7, day 15, day 29, day 57, week 12, week 16, 20, 26 after HAVG implantation. ] [ 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)


Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HAVG
Surgical placement of HAVG
Biological: HAVG
HAVG is implanted into patients' arm.

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 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 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 upper extremity to start or maintain hemodialysis therapy
  • Age 18 to 80 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 ≥8 g/dL and platelet count ≥100,000 cells/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 international normalized ratio (INR) ≤1.5 prior to Day 1.
  • Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able 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 6 months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
  • Uncontrolled or poorly controlled diabetes; hospitalization for poor glucose control within the previous 6 months is an absolute exclusion criterion
  • 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 6 months of study entry (Day 1)
  • Candidate for renal transplantation
  • Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
  • Treatment with vitamin K-antagonists, factor Xa inhibitors, or direct thrombin inhibitors within the month prior to study entry (Day 1)
  • Female patients who are pregnant, intending to become pregnant, nursing or intending to nurse during the study
  • Female patients of child bearing potential (not surgically sterile or at least 2 years post menopause) who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), eg, implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
  • History of cancer with active disease or treatment within the previous year
  • Immunodeficiency including AIDS / HIV
  • Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events (thromboses of previous dialysis accesses do not count)
  • Bleeding diathesis
  • Active clinically significant autoimmune disease
  • History of heparin-induced thrombocytopenia
  • 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 cells/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 unless low in the axilla and accessible for ultrasound monitoring and compression
  • Patients receiving a lower extremity AV access
  • Known serious allergy to aspirin
  • 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
  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: NCT01840956

Locations
United States, North Carolina
Duke University Medical Center Department of Vascular Surgery
Durham, North Carolina, United States, 27710
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
Sentara Norfolk General Hospital Vascular & Transplant Specialists
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Humacyte, Inc.
FGK Clinical Research GmbH
Aptiv Solutions
Investigators
Principal Investigator: Jeffrey H Lawson, MD PhD Department of Vascular Surgery Duke University Medical Center
  More Information

No publications provided

Responsible Party: Humacyte, Inc.
ClinicalTrials.gov Identifier: NCT01840956     History of Changes
Other Study ID Numbers: CLN-PRO-V003
Study First Received: April 18, 2013
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Humacyte, Inc.:
End-stage Renal Disease
Chronic Renal Insufficiency
Kidney Failure, Chronic
Hemodialysis
Renal Dialysis
Hemodiafiltration
Blood Vessel Prosthesis
Tissue-Engineered Vascular Graft
Vascular Prosthesis Implantation
Kidney Diseases
Renal Insufficiency
Urologic Diseases

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

ClinicalTrials.gov processed this record on October 23, 2014