Clinical trial NCT04905511: Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)
Official title: Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End Stage Renal Disease
Lead sponsor: Vascudyne, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, nonrandomized, single-arm, single-center, open-label
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety, adverse events
timeFrame: 26 weeks
measure: Patency
timeFrame: 26 weeks
Secondary outcomes:
measure: Immunology
timeFrame: baseline through 4 weeks
measure: Intervention rate
timeFrame: through 26 weeks
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Sanatario Italiano
Study officials:
affiliation: Sanatorio Italiano
name: Adrian Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.