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

NCT01744418 | Completed DMC

• 1 other identifier: CLN-PRO-V001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

End-stage Renal Disease; Kidney Failure, Chronic

Keywords

ESRD; HEMODIALYSIS; CHRONIC RENAL INSUFFICIENCY; Renal Dialysis; Hemodiafiltration; Blood Vessel Prosthesis; Tissue-Engineered Vascular Graft; Vascular Prosthesis Implantation

Outcome Measures

Primary Outcomes (2)

• 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.

• HAVG patency rate

  Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG.

  At 6 months after HAVG implantation.

Secondary Outcomes (4)

• PRA response

  At screening, day 15, 29, 57 and week 12, 26

• IgG antibodies

  At screening, day 15, 29, 57 and week 12, 26

• Patency maintenance/restoration

  At each visit except screening.

• HAVG patency rates

  At 12, 18, 24 months after HAVG implantation.

Study Arms (1)

HAVG graft

EXPERIMENTAL

HAVG graft implantation to study participants.

Device: HAVG graft implantation

Interventions

HAVG graft implantation DEVICE

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.

Also known as: Human Acellular Vascular Graft

HAVG graft

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Humacyte, Inc.: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (3)

Department of Vascular Surgery and Angiology at the Medical University Lublin

Lublin, 20-081, Poland

Location

Independent Public Central Clinical Hospital in Warsaw; Department of General, Vascular and Transplant Surgery

Warsaw, 02-097, Poland

Location

Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery

Wroclaw, 51-124, Poland

Location

Related 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 in patients with end-stage renal disease: two phase 2 single-arm trials. Lancet. 2016 May 14;387(10032):2026-34. doi: 10.1016/S0140-6736(16)00557-2.

  PMID: 27203778 RESULT

Related Links

• Results of the clinical study have been published

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shamik Parikh, MD

  Humacyte, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 6, 2012
• Study Start: November 22, 2012
• Primary Completion: December 1, 2014
• Study Completion: March 26, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)