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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905511
• Other study ID #: CIP-001
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: June 2022
• Source: Vascudyne, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
Paraguay	Sanatario Italiano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
Vascudyne, Inc.

Country where clinical trial is conducted

Paraguay, 

References & 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). pii: eaan4209. doi: 10.1126/scitranslmed.aan4209. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patency	time to loss of patency from implantation by Kaplan Meier	26 weeks
Secondary	Immunology	assess changes in panel reactive antibody (PRA) from baseline	baseline through 4 weeks
Secondary	Intervention rate	rate of interventions needed to maintain patency	through 26 weeks