Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

NCT01840956 | Completed Phase 1 DMC

• 1 other identifier: CLN-PRO-V003
• Study Type: interventional
• Target: 20
• 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

End-stage Renal Disease; Hemodialysis; Chronic Renal Insufficiency; Renal Dialysis; Hemodiafiltration; Blood Vessel Prosthesis; Tissue-Engineered Vascular Graft; Vascular Prosthesis Implantation; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Urologic Diseases

Outcome Measures

Primary Outcomes (4)

• HAVG graft assessment

  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.

  From baseline to week 26 after HAVG implantation.

• HAVG patency rate

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

  at Week 26 after HAVG implantation

• Adverse Events

  Frequency and severity of AEs of each patient will be documented.

  From baseline to week 26 after HAVG implantation.

• HAVG graft interventions

  Graft interventions of each patient will be documented.

  From baseline to week 26 after HAVG implantation.

Secondary Outcomes (4)

• Change from baseline in Panel Reactive Antibody

  From baseline to day 29, weeks 12 and 26 after HAVG implantation.

• Development of IgG antibodies

  From baseline to day 29, weeks 12 and 26 after HAVG implantation.

• Graft interventions

  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.

• HAVG patency rates

  at 12, 18, 24 months after HAVG implantation.

Study Arms (1)

HAVG

EXPERIMENTAL

Surgical placement of HAVG

Biological: HAVG

Interventions

HAVG BIOLOGICAL

HAVG is implanted into patients' arm.

HAVG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (3)

Duke University Medical Center Department of Vascular Surgery

Durham, North Carolina, 27710, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Sentara Norfolk General Hospital Vascular & Transplant Specialists

Norfolk, Virginia, 23507, United States

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; Kidney Diseases; Renal Insufficiency; Urologic Diseases

Condition Hierarchy (Ancestors)

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

• Lynda H Szczech, MD, MSCE

  Humacyte, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 26, 2013
• Study Start: May 23, 2013
• Primary Completion: April 28, 2016
• Study Completion: April 28, 2016
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)