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

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Phase 1

Locations

Paraguay

Study Type

Interventional

Intervention

natural human collagen arteriovenous graft for hemodialysis access

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanatario Italiano

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRUE Vascular Graft

Arm Description

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

Outcomes

Primary Outcome Measures

Safety, adverse events

incidence of clinically significant aneurysm, anastomotic bleeding, graft or anastomotic rupture, graft infection, and implant site irritation, inflammation, or infection

Patency

time to loss of patency from implantation by Kaplan Meier

Secondary Outcome Measures

Immunology

assess changes in panel reactive antibody (PRA) from baseline

Intervention rate

rate of interventions needed to maintain patency

Full Information

NCT ID

NCT04905511

First Posted

May 21, 2021

Last Updated

June 22, 2022

Sponsor

Vascudyne, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04905511

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

May 10, 2021 (Actual)

Primary Completion Date

February 15, 2022 (Actual)

Study Completion Date

June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vascudyne, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Prospective, nonrandomized, single-arm, single-center, open-label

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRUE Vascular Graft

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

natural human collagen arteriovenous graft for hemodialysis access

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety, adverse events

Description

incidence of clinically significant aneurysm, anastomotic bleeding, graft or anastomotic rupture, graft infection, and implant site irritation, inflammation, or infection

Time Frame

26 weeks

Title

Patency

Description

time to loss of patency from implantation by Kaplan Meier

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Immunology

Description

assess changes in panel reactive antibody (PRA) from baseline

Time Frame

baseline through 4 weeks

Title

Intervention rate

Description

rate of interventions needed to maintain patency

Time Frame

through 26 weeks

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian Ebner, MD

Organizational Affiliation

Sanatorio Italiano

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanatario Italiano

City

Asunción

Country

Paraguay

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29093182

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.

Results Reference

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

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