End Stage Renal DiseasePhase 1/2NCT05567757
Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)
A Phase 1/2 study testing Arteriovenous conduit implant in people with End Stage Renal Disease, run by Vascudyne, Inc. at 1 site in Panama.
Trial summary
Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study in subjects requiring hemodialysis. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Arteriovenous conduit implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 sitePanama
- Study dates
- 4 Oct 2022to 30 Mar 2025
- Phase
- Phase 1/2
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end stage kidney disease (ESKD) who are poor candidates for creation of a simple autogenous AV fistula (without requiring transposition) and therefore need placement of an AV access 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.
- Verify adequate arterial flow and venous runoff using duplex ultrasound and venogram. Ensure outflow vein is at least 5 mm in diameter with good compliance.
- Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 prior to implant.
- Other hematological and biochemical parameters within a range consistent with ESKD and acceptable for the administration of regional or general anesthesia prior to implant.
Show all 15Show fewer
- Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, and alkaline phosphatase ≤2x upper limit of normal or INR ≤ 1.5 prior to implant.
- Life expectancy of at least 1 year.
- Negative COVID-19 test within 3 days prior and negative for symptoms within 14 days prior to implant.
- Female subjects must be either:
- Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening)
- Or, of childbearing potential, in which case:
- Must have a negative urine blood pregnancy test at Screening, and ii. Must agree to use at least one form of the following birth control methods for the duration of the study:
- 1. Established use of oral, injectable or implanted hormonal methods of contraception 2. Placement of an intrauterine device or intrauterine system 3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository 11. Able to communicate meaningfully with investigative staff and able to comply with entire study procedures.
- 12. 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; ventricular tachyarrhythmias requiring continuing treatment; unstable angina; or ejection fraction < 50%.
- Uncontrolled or poorly controlled diabetes defined as A1C > 8; 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 study conduit implantation. Avoid patients with current subclavian catheters or leads on the side of the study conduit implant. If the patient had previous subclavian catheters or leads on the implant side, verify adequate runoff with a venogram.
- 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 3 months.
Show all 16Show fewer
- 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.
- Immunodeficiency including AIDS / HIV or active autoimmune disease, or on immunosuppressant therapy.
- Autoimmune nephropathy
- Previous PTFE graft in the operative limb unless the TRUE AVC can be placed more proximally than the previous failed graft.
- More than 1 failed PTFE graft in the operative limb.
- Patients receiving an AV access which crosses the elbow.
- Patients receiving a lower extremity AV access.
- Treatment with any investigational drug or device within 60 days prior to study entry or ongoing participation in a clinical trial of an investigational product.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study in subjects requiring hemodialysis. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104.
Read the detailed description
Twenty (20) patients with end-stage kidney disease (ESKD), who are poor candidates for an autogenous fistula creation and either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation will be implanted with a TRUE AVC as an arteriovenous conduit in the upper extremity. Study subjects will be evaluated for implant safety and patency at 26 weeks. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104.
- Conditions
- End Stage Renal Disease
- Being tested
- Arteriovenous conduit implant
- Keywords
- hemodialysis, arteriovenous 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.
Arteriovenous conduit implantBiological
Study subjects will be implanted with an arteriovenous shunt for hemodialysis access in the upper extremity
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Study subjects implanted with a TRUE AVC as an arteriovenous conduit for hemodialysis Receives: Biological: Arteriovenous conduit implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Incidence
incidence of clinically significant aneurysm, anastomotic bleeding, study conduit or anastomotic rupture, study conduit infection, and implant site irritation, inflammation, or infection
Measured: through 26 weeks post implant
Patency
Kaplan-Meier freedom from loss of primary patency, primary assisted patency, and secondary patency.
Measured: through 26 weeks post implant
Secondary outcomes (2)
Change in antigen sensitivity
Assess changes in anti-HLA sensitivity in each implant recipient, from baseline through four weeks, using panel reactive antibody (PRA) test
Measured: baseline through 4 weeks
Rate of Interventions
Rate of interventions needed to maintain patency
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start4 Oct 2022
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascudyne, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ernesto Alvarado, MD, Principal investigator, Centro de Asistencia Renal, Río Hato, Coclé, Panamá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567757
- Sponsor's protocol ID
- CIP-002
- Status last verified
- Jun 2025
- First submitted
- 27 Sep 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)
- ClinicalTrials.gov ID
- NCT05567757
- Acronym / sponsor ID
- CIP-002
- Conditions
- End Stage Renal Disease
- Keywords
- hemodialysis, arteriovenous access
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vascudyne, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 5 Oct 2022 (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, initial safety study in subjects requiring hemodialysis. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104.
Detailed description
Twenty (20) patients with end-stage kidney disease (ESKD), who are poor candidates for an autogenous fistula creation and either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation will be implanted with a TRUE AVC as an arteriovenous conduit in the upper extremity. Study subjects will be evaluated for implant safety and patency at 26 weeks. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104.
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, initial safety study
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Biological: Arteriovenous conduit implantStudy subjects implanted with a TRUE AVC as an arteriovenous conduit for hemodialysis |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with end stage kidney disease (ESKD) who are poor candidates for creation of a simple autogenous AV fistula (without requiring transposition) and therefore need placement of an AV access 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.
- Verify adequate arterial flow and venous runoff using duplex ultrasound and venogram. Ensure outflow vein is at least 5 mm in diameter with good compliance.
- Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 prior to implant.
Key exclusion criteria (16 listed)
- History or evidence of severe cardiac disease (NYHA Functional Class III or IV); myocardial infarction within six months prior to study entry; ventricular tachyarrhythmias requiring continuing treatment; unstable angina; or ejection fraction < 50%.
- Uncontrolled or poorly controlled diabetes defined as A1C > 8; 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 study conduit implantation. Avoid patients with current subclavian catheters or leads on the side of the study conduit implant. If the patient had previous subclavian catheters or leads on the implant side, verify adequate runoff with a venogram.
- 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 |
|---|---|---|
| Arteriovenous conduit implantStudy subjects will be implanted with an arteriovenous shunt for hemodialysis access in the upper extremity | Biological | Investigational |
Primary outcome
Adverse Event Incidence
Time frame: through 26 weeks post implant
incidence of clinically significant aneurysm, anastomotic bleeding, study conduit or anastomotic rupture, study conduit infection, and implant site irritation, inflammation, or infection
Patency
Time frame: through 26 weeks post implant
Kaplan-Meier freedom from loss of primary patency, primary assisted patency, and secondary patency.
2 secondary outcomes
Change in antigen sensitivity
Time frame: baseline through 4 weeks
Rate of Interventions
Time frame: 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 3 Jul 2025.
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Ernesto Alvarado, MD principal investigator
Centro de Asistencia Renal, Río Hato, Coclé, Panamá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arteriovenous conduit implant in people with End Stage Renal Disease, run by Vascudyne, Inc. at 1 site in Panama.
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 15 inclusion and 16 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 3 Jul 2025. 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 Panama. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse Event Incidence (time frame: through 26 weeks post implant). 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?
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 3 Jul 2025.