End-stage Renal DiseasePhase 1NCT01840956
Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
A Phase 1 study testing HAVG in people with End-stage Renal Disease and Kidney Failure, Chronic, run by Humacyte, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG. The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-stage Renal Disease, Kidney Failure, Chronic
- What is being tested?
- HAVG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 May 2013to 28 Apr 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 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 upper extremity to start or maintain hemodialysis therapy
- Age 18 to 80 years old, inclusive
- Suitable anatomy for implantation of straight forearm grafts or curved upper arm grafts (arterial anastomosis to radial or brachial artery, venous anastomosis to either brachial cephalic or very central basilica vein)
- Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 1
- Other hematological and biochemical parameters within a range consistent with ESRD and acceptable for the administration of general anesthesia prior to Day 1
- Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, and alkaline phosphatase ≤2x upper limit of normal or international normalized ratio (INR) ≤1.5 prior to Day 1.
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- Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures
- Able and willing to give informed consent
- Life expectancy of at least 1 year
Who cannot join
- History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within 6 months of 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 is an absolute exclusion criterion
- 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
- Stroke within 6 months of study entry (Day 1)
- Candidate for renal transplantation
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- Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
- Treatment with vitamin K-antagonists, factor Xa inhibitors, or direct thrombin inhibitors within the month prior to study entry (Day 1)
- Female patients who are pregnant, intending to become pregnant, nursing or intending to nurse during the study
- Female patients of child bearing potential (not surgically sterile or at least 2 years post menopause) who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), eg, implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
- History of cancer with active disease or treatment within the previous year
- Immunodeficiency including AIDS / HIV
- Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events (thromboses of previous dialysis accesses do not count)
- Bleeding diathesis
- Active clinically significant autoimmune disease
- History of heparin-induced thrombocytopenia
- Previous PTFE graft in the operative limb unless the HAVG can be placed more proximally than the previous failed graft
- More than 1 failed PTFE graft in the operative limb
- Active local or systemic infection (WBC > 15,000 cells/mm3)
- Patients receiving a forearm graft with which crosses the elbow
- Patients receiving an upper arm graft with arterial anastomosis to the axillary artery or venous anastomosis to the axillary vein unless low in the axilla and accessible for ultrasound monitoring and compression
- Patients receiving a lower extremity AV access
- Known serious allergy to aspirin
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAVG
- Previous enrollment in this study
- Employees of the sponsor or patients who are employees or relatives of the investigator
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University Medical Center Department of Vascular Surgery
Durham, North Carolina, 27710
The Methodist Hospital
Houston, Texas, 77030
Sentara Norfolk General Hospital Vascular & Transplant Specialists
Norfolk, Virginia, 23507
About this study
Official title: A Phase I Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.
Read the detailed description
The HAVG is a sterile, non-pyrogenic, acellular tubular graft composed of human collagens and other natural extra-cellular matrix proteins. Upon implantation, it is anticipated (based on pre-clinical studies) that the collagen-based matrix comprising the graft will be infiltrated with host cells and re-modeled by the host. This will result in a vascular structure more similar to the histological composition of the native vascular tissue that may improve graft longevity and be less likely to become infected.
- Conditions
- End-stage Renal Disease, Kidney Failure, Chronic
- Being tested
- HAVG
- Keywords
- End-stage Renal Disease, Hemodialysis, Chronic Renal Insufficiency, Renal Dialysis, Hemodiafiltration, Blood Vessel Prosthesis, Tissue-Engineered Vascular Graft, Vascular Prosthesis Implantation, Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency, Urologic Diseases
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Kidney Diseases, Renal Insufficiency, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAVGBiological
HAVG is implanted into patients' arm.
| Study group | Role | What they receive |
|---|---|---|
| HAVG | Experimental | Surgical placement of HAVG Receives: Biological: HAVG |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAVG graft assessment
The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be assessed by Doppler ultrasound and tabulated.
Measured: From baseline to week 26 after HAVG implantation.
HAVG patency rate
Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG by Doppler ultrasound.
Measured: at Week 26 after HAVG implantation
Adverse Events
Frequency and severity of AEs of each patient will be documented.
Measured: From baseline to week 26 after HAVG implantation.
HAVG graft interventions
Graft interventions of each patient will be documented.
Measured: From baseline to week 26 after HAVG implantation.
Secondary outcomes (4)
Change from baseline in Panel Reactive Antibody
Assess changes in the Panel Reactive Antibody response over the 6 months after graft implantation.
Measured: From baseline to day 29, weeks 12 and 26 after HAVG implantation.
Development of IgG antibodies
Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG.
Measured: From baseline to day 29, weeks 12 and 26 after HAVG implantation.
Graft interventions
Determine the rates of interventions needed to maintain / restore patency in the graft.
Measured: At each visit, i.e. day 1, day 4-7, day 15, day 29, day 57, week 12, week 16, 20, 26 after HAVG implantation.
HAVG patency rates
Patency rates (primary, primary assisted, and secondary)
Measured: at 12, 18, 24 months after HAVG implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study start23 May 2013
- Primary completion28 Apr 2016
- Study completion28 Apr 2016
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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH, Aptiv Solutions
- Responsible party
- Sponsor
- Investigators
- Lynda H Szczech, MD, MSCE, Study director, Humacyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840956
- Sponsor's protocol ID
- CLN-PRO-V003
- Status last verified
- Aug 2022
- First submitted
- 18 Apr 2013
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lawson JH, Glickman MH, Ilzecki M, Jakimowicz T, Jaroszynski A, Peden EK, Pilgrim AJ, Prichard HL, Guziewicz M, Przywara S, Szmidt J, Turek J, Witkiewicz W, Zapotoczny N, Zubilewicz T, Niklason LE. Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials. Lancet. 2016 May 14;387(10032):2026-34. doi: 10.1016/S0140-6736(16)00557-2.
PubMed 27203778
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT01840956
- Acronym / sponsor ID
- CLN-PRO-V003
- Conditions
- End-stage Renal Disease, Kidney Failure, Chronic
- Keywords
- End-stage Renal Disease, Hemodialysis, Chronic Renal Insufficiency, Renal Dialysis, Hemodiafiltration, Blood Vessel Prosthesis, Tissue-Engineered Vascular Graft, Vascular Prosthesis Implantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH, Aptiv Solutions
- Study start
- 23 May 2013 (actual)
- Primary completion
- 28 Apr 2016 (actual)
- Study completion
- 28 Apr 2016 (actual)
- First posted
- 26 Apr 2013 (estimated)
- 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.
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.
Detailed description
The HAVG is a sterile, non-pyrogenic, acellular tubular graft composed of human collagens and other natural extra-cellular matrix proteins. Upon implantation, it is anticipated (based on pre-clinical studies) that the collagen-based matrix comprising the graft will be infiltrated with host cells and re-modeled by the host. This will result in a vascular structure more similar to the histological composition of the native vascular tissue that may improve graft longevity and be less likely to become infected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAVG | Experimental | Biological: HAVGSurgical placement of HAVG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients 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 upper extremity to start or maintain hemodialysis therapy
- Age 18 to 80 years old, inclusive
- Suitable anatomy for implantation of straight forearm grafts or curved upper arm grafts (arterial anastomosis to radial or brachial artery, venous anastomosis to either brachial cephalic or very central basilica vein)
- Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 1
- Other hematological and biochemical parameters within a range consistent with ESRD and acceptable for the administration of general anesthesia prior to Day 1
Key exclusion criteria (26 listed)
- History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within 6 months of 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 is an absolute exclusion criterion
- 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
- Stroke within 6 months of study entry (Day 1)
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 |
|---|---|---|
| HAVGHAVG is implanted into patients' arm. | Biological | HAVG |
Primary outcome
HAVG graft assessment
Time frame: From baseline to week 26 after HAVG implantation.
The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be assessed by Doppler ultrasound and tabulated.
HAVG patency rate
Time frame: at Week 26 after HAVG implantation
Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG by Doppler ultrasound.
Adverse Events
Time frame: From baseline to week 26 after HAVG implantation.
Frequency and severity of AEs of each patient will be documented.
HAVG graft interventions
Time frame: From baseline to week 26 after HAVG implantation.
Graft interventions of each patient will be documented.
4 secondary outcomes
Change from baseline in Panel Reactive Antibody
Time frame: From baseline to day 29, weeks 12 and 26 after HAVG implantation.
Development of IgG antibodies
Time frame: From baseline to day 29, weeks 12 and 26 after HAVG implantation.
Graft interventions
Time frame: At each visit, i.e. day 1, day 4-7, day 15, day 29, day 57, week 12, week 16, 20, 26 after HAVG implantation.
HAVG patency rates
Time frame: at 12, 18, 24 months after HAVG implantation.
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 19 Aug 2022.
- Results publication: PubMed 27203778Lawson JH, Glickman MH, Ilzecki M, Jakimowicz T, Jaroszynski A, Peden EK, Pilgrim AJ, Prichard HL, Guziewicz M, Przywara S, Szmidt J, Turek J, Witkiewicz W, Zapotoczny N, Zubilewicz T, Niklason LE. Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials. Lancet. 2016 May 14;387(10032):2026-34. doi: 10.1016/S0140-6736(16)00557-2.
- Results of the clinical study have been publishedLink provided by the sponsor.
- 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.
Lynda H Szczech, MD, MSCE study director
Humacyte, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HAVG in people with End-stage Renal Disease and Kidney Failure, Chronic, run by Humacyte, Inc. at 3 sites in United States.
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 9 inclusion and 26 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
HAVG graft assessment (time frame: From baseline to week 26 after HAVG 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?
On the ClinicalTrials.gov record for NCT01840956, 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 19 Aug 2022.