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

Phase 1

Completed

• Conditions: End Stage Renal Disease
• Interventions: Biological: natural human collagen arteriovenous graft for hemodialysis access

• Registration Number: NCT04905511
• Lead Sponsor: Vascudyne, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2021-05-10
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-27
• Primary Completion: 2022-02-15
• Status Verified: 2022-06
• Study Completion: 2022-06-15
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRUE Vascular Graft	natural human collagen arteriovenous graft for hemodialysis access	Patients will be implanted with the TRUE Vascular Graft in the upper arm or forearm

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sanatario Italiano; 🇵🇾 Asunción, Paraguay