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

Sponsor

Humacyte, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01744418

Collaborator

FGK Clinical Research GmbH (Industry)

Enrollment

Locations

Arm

144.3

Anticipated Duration (Months)

13.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
End-stage Renal Disease Kidney Failure, Chronic	Device: HAVG graft implantation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Actual Study Start Date :

Nov 22, 2012

Actual Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Human Acellular Vascular Graft

Arm

Intervention/Treatment

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 Names:

Human Acellular Vascular Graft

Outcome Measures

Primary Outcome Measures

HAVG safety & tolerability [At each visit within first 6 months after HAVG implantation.]
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 [At 6 months after HAVG implantation.]
Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG.

Secondary Outcome Measures

PRA response [At screening, day 15, 29, 57 and week 12, 26]
Assess changes in the PRA response over the 6 months after graft implantation.
IgG antibodies [At screening, day 15, 29, 57 and week 12, 26]
Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG.
Patency maintenance/restoration [At each visit except screening.]
Determine the rates of interventions needed to maintain / restore patency in the graft.
HAVG patency rates [At 12, 18, 24 months after HAVG implantation.]
Patency rates (primary, primary assisted and secondary) at 12, 18 and 24 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Department of Vascular Surgery and Angiology at the Medical University Lublin	Lublin	Poland	20-081
2	Independent Public Central Clinical Hospital in Warsaw; Department of General, Vascular and Transplant Surgery	Warsaw	Poland	02-097
3	Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery	Wroclaw	Poland	51-124