Renal FailurePhase 2NCT04135417
Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
A Phase 2 study testing HAV in people with Renal Failure and End Stage Renal Disease, run by Humacyte, Inc. at 2 sites in Poland.
Trial summary
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, End Stage Renal Disease, Vascular Access
- What is being tested?
- HAV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPoland
- Study dates
- 12 Nov 2019to 2 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with ESRD who are not, or who are no longer candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the arm (upper or forearm) for hemodialysis therapy.
- Already established on hemodialysis
- At least 18 years of age at Screening.
- Suitable arterial and venous anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow).
- Hemoglobin ≥ 8 g/dL and platelet count ≥ 100,000 cells/mm3 prior to Day 0 (within 45 days).
- Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 45 days).
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- Normal clotting (international normalized ration [INR] ≤ 1.5 or prothrombin time ≤ 18 sec unless the patient is taking an anticoagulant for an approved indication at the time of HAV implantation.
- 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 serum or urine 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 9. Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.
- 10. Life expectancy of at least 1 year.
Who cannot join
- History or evidence of severe peripheral vascular disease in the intended arm for implantation.
- Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of the planned implantation, unless the stenosis is corrected prior to HAV implantation.
- Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
- Cancer that is actively being treated with a cytotoxic agent.
- Documented hyper-coagulable state as defined as either:
- a biochemical diagnosis (e.g. Factor V Leiden, Protein C deficiency, etc.) - OR -
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- a clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g deep vein thrombosis, pulmonary embolism, etc.) within the 5 previous years.
- Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g. von Willebrand disease, etc.).
- Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
- Low dose glucocorticoid therapy (e.g. up to 10 mg a day prednisone or prednisolone) is acceptable.
- High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
- Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
- The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
- tacrolimus or FK506 [Prograf] ii. mycophenolate mofetil [Cellcept], iii. cyclosporine [Sandimmune or Gengraf] iv. Sirolimus administered systemically (Sirolimus in drug eluting stents is NOT an exclusion)
- Anticipated renal transplant within 6 months.
- Venous outflow from HAV cannot be placed more centrally than the venous outflow of any previous failed access on that extremity.
- Active local or systemic infection (white blood cells [WBC] > 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least 1 week post resolution of that infection before implantation.
- Known serious allergy to planned antiplatelet agent.
- Pregnant women, or women intending to become pregnant during the course of the trial.
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAV.
- Previous enrollment in this study or any other study with HAV.
- Employees of Humacyte and employees or relatives of the investigator.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Szpital Kliniczny Przemienienia Pańskiego UM w Poznaniu, Klinika Chirurgii Ogólnej i Naczyń
Poznan, 61-848
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Oddział Chirurgii Naczyniowej
Wroclaw, 51-124
About this study
Official title: A Phase 2 Assessment of Humacyte's Human Acellular Vessel in Patients Needing Vascular Access for Dialysis
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).
Read the detailed description
This is a Phase 2, prospective, multicenter, open-label, single-arm study. Subjects who sign informed consent would undergo study-specific screening assessments within 45 days from the day of informed consent.
Eligible study subjects will receive a HAV and will be followed to 12 months post-implantation at routine study visits regardless of patency status. After 12 months, subjects with a patent HAV will be followed (while the HAV remains patent) for up to 2 years (24 months) post implantation at study visits every 6 months.
- Conditions
- Renal Failure, End Stage Renal Disease, Vascular Access, Hemodialysis
- Being tested
- HAV
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAVBiological
Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
| Study group | Role | What they receive |
|---|---|---|
| HAV | Experimental | The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. HAV for this study will be manufactured using the commercial manufacturing system.It will be implanted in the forearm or upper arm using standard vascular surgical techniques. All subjects will be required to start taking daily aspirin (75 or 325 mg) on Day 1 after surgical implantation of HAV unless they are already taking another antiplatelet agent. If low molecular weight heparin (LMWH) is administered post-operatively, aspirin or other antiplatelet agents should be initiated after stopping LMWH. Subjects who are known to be aspirin-sensitive should take another antiplatelet agent at the discretion of the Principal Investigator. Receives: Biological: HAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Number of Subjects With Adverse Events Indicating Possible Mechanical Failure or Weakness of the HAV
Frequency and severity of AEs of each patient will be documented
Measured: Up to 3 months post-implantation
Number of Participants With Baseline Change of Panel Reactive Antibody (PRA) Value
Assess changes in the PRA response (number of participants) over the 2 months after graft implantation
Measured: 2 months post implantation
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Frequency and severity of all adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) of each patient will be documented.
Measured: Up to 3 months post-implantation
Number of Participants With Primary Patency, Primary Assisted Patency and Secondary Patency
Measured: 3 months post-implantation
Secondary outcomes (2)
Number of Participants With Baseline Change of Panel Reactive Antibody (PRA) Value
Assess changes in the PRA response (number of subjects) over the 12 months after graft implantation
Measured: 12 months post-implantation
Number of Participants With All AEs/SAEs
Frequency and severity of AEs/SAE of each patient will be documented
Measured: Up to 12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start12 Nov 2019
- Primary completion15 May 2021
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shamik Shamik, MD, Study director, Humacyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135417
- Sponsor's protocol ID
- CLN-PRO-V011
- Status last verified
- Feb 2024
- First submitted
- 16 Oct 2019
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Assessment of Humacyte's Human Acellular Vessel in Patients Needing Vascular Access for Dialysis
- ClinicalTrials.gov ID
- NCT04135417
- Acronym / sponsor ID
- CLN-PRO-V011
- Conditions
- Renal Failure, End Stage Renal Disease, Vascular Access, Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Posted 23 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).
Detailed description
This is a Phase 2, prospective, multicenter, open-label, single-arm study. Subjects who sign informed consent would undergo study-specific screening assessments within 45 days from the day of informed consent.
Eligible study subjects will receive a HAV and will be followed to 12 months post-implantation at routine study visits regardless of patency status. After 12 months, subjects with a patent HAV will be followed (while the HAV remains patent) for up to 2 years (24 months) post implantation at study visits every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAV | Experimental | Biological: HAVThe HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. HAV for this study will be manufactured using the commercial manufacturing system.It will be implanted in the forearm or upper arm using standard vascular surgical techniques. All subjects will be required to start taking daily aspirin (75 or 325 mg) on Day 1 after surgical implantation of HAV unless they are already taking another antiplatelet agent. If low molecular weight heparin (LMWH) is administered post-operatively, aspirin or other antiplatelet agents should be initiated after stopping LMWH. Subjects who are known to be aspirin-sensitive should take another antiplatelet agent at the discretion of the Principal Investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with ESRD who are not, or who are no longer candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the arm (upper or forearm) for hemodialysis therapy.
- Already established on hemodialysis
- At least 18 years of age at Screening.
- Suitable arterial and venous anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow).
- Hemoglobin ≥ 8 g/dL and platelet count ≥ 100,000 cells/mm3 prior to Day 0 (within 45 days).
Key exclusion criteria (22 listed)
- History or evidence of severe peripheral vascular disease in the intended arm for implantation.
- Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of the planned implantation, unless the stenosis is corrected prior to HAV implantation.
- Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
- Cancer that is actively being treated with a cytotoxic agent.
- Documented hyper-coagulable state as defined as either:
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 |
|---|---|---|
| HAVSurgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access. | Biological | HAV |
Primary outcome
Cumulative Number of Subjects With Adverse Events Indicating Possible Mechanical Failure or Weakness of the HAV
Time frame: Up to 3 months post-implantation
Frequency and severity of AEs of each patient will be documented
Number of Participants With Baseline Change of Panel Reactive Antibody (PRA) Value
Time frame: 2 months post implantation
Assess changes in the PRA response (number of participants) over the 2 months after graft implantation
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Time frame: Up to 3 months post-implantation
Frequency and severity of all adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) of each patient will be documented.
Number of Participants With Primary Patency, Primary Assisted Patency and Secondary Patency
Time frame: 3 months post-implantation
2 secondary outcomes
Number of Participants With Baseline Change of Panel Reactive Antibody (PRA) Value
Time frame: 12 months post-implantation
Number of Participants With All AEs/SAEs
Time frame: Up to 12 months post-implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shamik Shamik, MD study director
Humacyte, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HAV in people with Renal Failure and End Stage Renal Disease, run by Humacyte, Inc. at 2 sites in Poland.
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 13 inclusion and 22 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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 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?
Yes. Results are posted in the registry (first posted 23 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative Number of Subjects With Adverse Events Indicating Possible Mechanical Failure or Weakness of the HAV (time frame: Up to 3 months post-implantation). The study lists 4 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 19 Mar 2024.