Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)

Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Biological: natural human collagen arteriovenous graft for hemodialysis access

Detailed Description

Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation. Subjects will be followed regularly with office visits at the investigational site at days 15, 29, 57 and weeks 12, 26 for vessel imaging, blood draws and other follow-up tests.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Sanatario Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with end stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of a simple autogenous AV fistula (radio-cephalic or brachio-cephalic without requiring transposition) and therefore need placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy.
• Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.
• Patients between 18 and 75 years old, inclusive.
• Life expectancy of at least 1 year.
• Negative COVID-19 test within 3 days prior to surgery and negative for symptoms within 14 days prior to surgery.
• Able to communicate meaningfully with investigative staff and able to comply with entire study procedures.
• Willing and competent to give written informed consent.

Exclusion Criteria:

• History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
• Uncontrolled or poorly controlled diabetes; hospitalization for poor glucose control within the previous 6 months.
• 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.
• Documented hypercoagulable state or history of thromboembolic events or history of repeated venous catheter clotting.
• Known Positive COVID 19 test result or known exposure to COVID 19 in past 4 months.
• Known active infection including dental infection, osteomyelitis and other conditions which could present a local or systemic risk of infection.
• Bleeding diathesis.
• Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet therapy. History of heparin-induced thrombocytopenia.
• Contraindication to or known serious allergy to penicillin.
• Ongoing therapy with vitamin K antagonists or direct thrombin inhibitors or factor Xa inhibitors.
• Immunodeficiency including AIDS / HIV or active autoimmune disease, or on immunosuppressant therapy.
• Previous PTFE graft in the operative limb unless the TRUE graft can be placed more proximally than the previous failed graft.
• More than 1 failed PTFE graft in the operative limb.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRUE Vascular Graft; Patients will be implanted with the TRUE Vascular Graft in the upper arm or forearm	Biological: natural human collagen arteriovenous graft for hemodialysis access; The True Vascular Graft will be implanted in the forearm or upper arm in a straight or curved configuration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, adverse events	incidence of clinically significant aneurysm, anastomotic bleeding, graft or anastomotic rupture, graft infection, and implant site irritation, inflammation, or infection	26 weeks
Patency	time to loss of patency from implantation by Kaplan Meier	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunology	assess changes in panel reactive antibody (PRA) from baseline	baseline through 4 weeks
Intervention rate	rate of interventions needed to maintain patency	through 26 weeks

Collaborators and Investigators

• Sponsor: Vascudyne, Inc.
• Investigators: Principal Investigator: Adrian Ebner, MD, Sanatorio Italiano

Publications and helpful links

General Publications

• Syedain ZH, Graham ML, Dunn TB, O'Brien T, Johnson SL, Schumacher RJ, Tranquillo RT. A completely biological "off-the-shelf" arteriovenous graft that recellularizes in baboons. Sci Transl Med. 2017 Nov 1;9(414):eaan4209. doi: 10.1126/scitranslmed.aan4209.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: CIP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes