Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
10

Inclusion Criteria

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
Patients between 18 and 75 years old, inclusive
...
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
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)
Life expectancy of at least 1 year
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
Other hematological and biochemical parameters within a range consistent with ESRD and acceptable for the administration of general anesthesia prior to Day 1
Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 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.

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
PRA > 20% (first 10 patients only)
Active local or systemic infection (WBC > 15,000/mm3)
...
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
PRA > 20% (first 10 patients only)
Active local or systemic infection (WBC > 15,000/mm3)
Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAVG
Known or suspected central vein obstruction on the side of planned graft implantation
Bleeding diathesis
History or evidence of severe peripheral vascular disease in the upper limbs
Immunodeficiency including AIDS / HIV
Active autoimmune disease
Known serious allergy to aspirin or penicillin
Employees of the sponsor or patients who are employees or relatives of the investigator
Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
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
Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
Patients receiving a lower extremity AV access
Treatment with vitamin K-antagonists or direct thrombin inhibitors within the previous month to study entry (Day 1)
Previous PTFE graft in the operative limb unless the HAVG can be placed more proximally than the previous failed graft
Active diagnosis of cancer within the previous year
Patients receiving an upper arm graft with arterial anastomosis to the axillary artery or venous anastomosis to the axillary vein
Stroke within six (6) months of study entry (Day 1)
Patients receiving a forearm graft with which crosses the elbow
Previous enrollment in this study
More than 1 failed PTFE graft in the operative limb

Summary

Conditions
  • End Stage Renal Disease
  • Kidney Failure Chronic
  • End-stage Renal Disease
  • Kidney Failure, Chronic
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

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...

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.

Inclusion Criteria

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
Patients between 18 and 75 years old, inclusive
...
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
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)
Life expectancy of at least 1 year
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
Other hematological and biochemical parameters within a range consistent with ESRD and acceptable for the administration of general anesthesia prior to Day 1
Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 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.

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
PRA > 20% (first 10 patients only)
Active local or systemic infection (WBC > 15,000/mm3)
...
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
PRA > 20% (first 10 patients only)
Active local or systemic infection (WBC > 15,000/mm3)
Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAVG
Known or suspected central vein obstruction on the side of planned graft implantation
Bleeding diathesis
History or evidence of severe peripheral vascular disease in the upper limbs
Immunodeficiency including AIDS / HIV
Active autoimmune disease
Known serious allergy to aspirin or penicillin
Employees of the sponsor or patients who are employees or relatives of the investigator
Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
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
Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
Patients receiving a lower extremity AV access
Treatment with vitamin K-antagonists or direct thrombin inhibitors within the previous month to study entry (Day 1)
Previous PTFE graft in the operative limb unless the HAVG can be placed more proximally than the previous failed graft
Active diagnosis of cancer within the previous year
Patients receiving an upper arm graft with arterial anastomosis to the axillary artery or venous anastomosis to the axillary vein
Stroke within six (6) months of study entry (Day 1)
Patients receiving a forearm graft with which crosses the elbow
Previous enrollment in this study
More than 1 failed PTFE graft in the operative limb

Tracking Information

NCT #
NCT01744418
Collaborators
FGK Clinical Research GmbH
Investigators
  • Study Director: Kiernan DeAngelis, MD Humacyte, Inc.
  • Study Director: Lynda Szczech, MD, MSCE Humacyte, Inc.
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