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

NCT04905511 | Completed Phase 1 FDA Drug

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Immunology

  baseline through 4 weeks

• Intervention rate

  through 26 weeks

Study Arms (1)

TRUE Vascular Graft

EXPERIMENTAL

Patients will be implanted with the TRUE Vascular Graft in the upper arm or forearm

Biological: natural human collagen arteriovenous graft for hemodialysis access

Interventions

natural human collagen arteriovenous graft for hemodialysis access BIOLOGICAL

The True Vascular Graft will be implanted in the forearm or upper arm in a straight or curved configuration.

TRUE Vascular Graft

Eligibility Criteria

• Age: 18 Years - 75 Years
• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vascudyne, Inc.: lead

Study Sites (1)

Sanatario Italiano

Asunción, Paraguay

Location

Related Publications (1)

• 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.

  PMID: 29093182 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

• Adrian Ebner, MD

  Sanatorio Italiano

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective, nonrandomized, single-arm, single-center, open-label

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 27, 2021
• Study Start: May 10, 2021
• Primary Completion: February 15, 2022
• Study Completion: June 15, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)