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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01744418
• Other study ID #: CLN-PRO-V001
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 22, 2012
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Humacyte, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Vascular Surgery and Angiology at the Medical University Lublin	Lublin
Poland	Independent Public Central Clinical Hospital in Warsaw; Department of General, Vascular and Transplant Surgery	Warsaw
Poland	Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Humacyte, Inc.	FGK Clinical Research GmbH

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Lawson JH, Glickman MH, Ilzecki M, Jakimowicz T, Jaroszynski A, Peden EK, Pilgrim AJ, Prichard HL, Guziewicz M, Przywara S, Szmidt J, Turek J, Witkiewicz W, Zapotoczny N, Zubilewicz T, Niklason LE. Bioengineered human acellular vessels for dialysis access — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAVG safety & tolerability	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.	At each visit within first 6 months after HAVG implantation.
Primary	HAVG patency rate	Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG.	At 6 months after HAVG implantation.
Secondary	PRA response	Assess changes in the PRA response over the 6 months after graft implantation.	At screening, day 15, 29, 57 and week 12, 26
Secondary	IgG antibodies	Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG.	At screening, day 15, 29, 57 and week 12, 26
Secondary	Patency maintenance/restoration	Determine the rates of interventions needed to maintain / restore patency in the graft.	At each visit except screening.
Secondary	HAVG patency rates	Patency rates (primary, primary assisted and secondary) at 12, 18 and 24 months.	At 12, 18, 24 months after HAVG implantation.

External Links

•   Results of the clinical study have been published