End Stage Renal DiseasePhase 1NCT04905511
Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)
A Phase 1 study testing natural human collagen arteriovenous graft for hemodialysis access in people with End Stage Renal Disease, run by Vascudyne, Inc. at 1 site in Paraguay.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- natural human collagen arteriovenous graft for hemodialysis access
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteParaguay
- Study dates
- 10 May 2021to 15 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- natural human collagen arteriovenous graft for hemodialysis access
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural human collagen arteriovenous graft for hemodialysis accessBiological
The True Vascular Graft will be implanted in the forearm or upper arm in a straight or curved configuration.
| Study group | Role | What they receive |
|---|---|---|
| TRUE Vascular Graft | Experimental | Patients will be implanted with the TRUE Vascular Graft in the upper arm or forearm Receives: Biological: natural human collagen arteriovenous graft for hemodialysis access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, adverse events
incidence of clinically significant aneurysm, anastomotic bleeding, graft or anastomotic rupture, graft infection, and implant site irritation, inflammation, or infection
Measured: 26 weeks
Patency
time to loss of patency from implantation by Kaplan Meier
Measured: 26 weeks
Secondary outcomes (2)
Immunology
assess changes in panel reactive antibody (PRA) from baseline
Measured: baseline through 4 weeks
Intervention rate
rate of interventions needed to maintain patency
Measured: through 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start10 May 2021
- Primary completion15 Feb 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, nonrandomized, single-arm, single-center, open-label
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascudyne, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, MD, Principal investigator, Sanatorio Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905511
- Sponsor's protocol ID
- CIP-001
- Status last verified
- Jun 2022
- First submitted
- 21 May 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29093182
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)
- ClinicalTrials.gov ID
- NCT04905511
- Acronym / sponsor ID
- CIP-001
- Conditions
- End Stage Renal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vascudyne, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, nonrandomized, single-arm, single-center, open-label
| Arm | Type | Receives |
|---|---|---|
| TRUE Vascular Graft | Experimental | Biological: natural human collagen arteriovenous graft for hemodialysis accessPatients will be implanted with the TRUE Vascular Graft in the upper arm or forearm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natural human collagen arteriovenous graft for hemodialysis accessThe True Vascular Graft will be implanted in the forearm or upper arm in a straight or curved configuration. | Biological | TRUE Vascular Graft |
Primary outcome
Safety, adverse events
Time frame: 26 weeks
incidence of clinically significant aneurysm, anastomotic bleeding, graft or anastomotic rupture, graft infection, and implant site irritation, inflammation, or infection
Patency
Time frame: 26 weeks
time to loss of patency from implantation by Kaplan Meier
2 secondary outcomes
Immunology
Time frame: baseline through 4 weeks
Intervention rate
Time frame: through 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Background: PubMed 29093182Syedain 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Ebner, MD principal investigator
Sanatorio Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing natural human collagen arteriovenous graft for hemodialysis access in people with End Stage Renal Disease, run by Vascudyne, Inc. at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, adverse events (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04905511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.