End-stage Renal DiseaseNCT01744418
Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD
A study testing HAVG graft implantation in people with End-stage Renal Disease and Kidney Failure, Chronic, run by Humacyte, Inc. at 3 sites in Poland.
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 75 years
- Conditions the study is for
- End-stage Renal Disease, Kidney Failure, Chronic
- What is being tested?
- HAVG graft implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesPoland
- Study dates
- 22 Nov 2012to 26 Mar 2024
- Phase
- Interventional
- 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 an autogenous AV fistula and therefore need placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
- Patients between 18 and 75 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 ≥8g/dL and platelet count ≥100,000/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 INR ≤ 1.5 prior to Day 1.
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- Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability 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 six months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- 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 six (6) months of study entry (Day 1)
- Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
- Treatment with vitamin K-antagonists or direct thrombin inhibitors within the previous month to study entry (Day 1)
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- All patients (including both female patients of childbearing potential and male patients with childbearing potential partners) who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), e.g. implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
- Active diagnosis of cancer within the previous year
- Immunodeficiency including AIDS / HIV
- Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
- Bleeding diathesis
- Active autoimmune disease
- 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/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
- Patients receiving a lower extremity AV access
- Known serious allergy to aspirin or penicillin
- 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
- PRA > 20% (first 10 patients only)
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Department of Vascular Surgery and Angiology at the Medical University Lublin
Lublin, 20-081
Independent Public Central Clinical Hospital in Warsaw; Department of General, Vascular and Transplant Surgery
Warsaw, 02-097
Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery
Wroclaw, 51-124
About this study
Official title: A Pilot Study for Evaluation of the 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 graft implantation
- Keywords
- ESRD, HEMODIALYSIS, CHRONIC RENAL INSUFFICIENCY, Renal Dialysis, Hemodiafiltration, Blood Vessel Prosthesis, Tissue-Engineered Vascular Graft, Vascular Prosthesis Implantation
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAVG graft implantationDevice
Also called Human Acellular Vascular Graft
Patients will be implanted with a Human Acellular Vascular Graft (HAVG) in the forearm or upper arm (arterial anastomosis to the radial or brachial artery, venous anastomosis to either the brachial, cephalic or very central basilica vein) using standard vascular surgical techniques. The graft will be placed in a straight or curved configuration in the first 10 patients. Loop grafts may be permitted in subsequent patients subject to acceptable graft performance at the interim safety review. Placing the graft across the elbow will be avoided.
| Study group | Role | What they receive |
|---|---|---|
| HAVG graft | Experimental | HAVG graft implantation to study participants. Receives: Device: HAVG graft implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAVG safety & tolerability
The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be tabulated by visit and overall.
Measured: At each visit within first 6 months after HAVG implantation.
HAVG patency rate
Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG.
Measured: At 6 months after HAVG implantation.
Secondary outcomes (4)
PRA response
Assess changes in the PRA response over the 6 months after graft implantation.
Measured: At screening, day 15, 29, 57 and week 12, 26
IgG antibodies
Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG.
Measured: At screening, day 15, 29, 57 and week 12, 26
Patency maintenance/restoration
Determine the rates of interventions needed to maintain / restore patency in the graft.
Measured: At each visit except screening.
HAVG patency rates
Patency rates (primary, primary assisted and secondary) at 12, 18 and 24 months.
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 posted6 Dec 2012 (estimated)
- Study start22 Nov 2012
- Primary completionDec 2014
- Study completion26 Mar 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Shamik Parikh, MD, Study director, Humacyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744418
- Sponsor's protocol ID
- CLN-PRO-V001
- Status last verified
- Nov 2024
- First submitted
- 5 Dec 2012
- Last updated
- 13 Nov 2024
- 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 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Evaluation of the 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
- NCT01744418
- Acronym / sponsor ID
- CLN-PRO-V001
- Conditions
- End-stage Renal Disease, Kidney Failure, Chronic
- Keywords
- ESRD, HEMODIALYSIS, CHRONIC RENAL INSUFFICIENCY, Renal Dialysis, Hemodiafiltration, Blood Vessel Prosthesis, Tissue-Engineered Vascular Graft, Vascular Prosthesis Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 22 Nov 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 6 Dec 2012 (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 graft | Experimental | Device: HAVG graft implantationHAVG graft implantation to study participants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with end stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula and therefore need placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
- Patients between 18 and 75 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 ≥8g/dL and platelet count ≥100,000/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 (23 listed)
- History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- 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 six (6) months of study entry (Day 1)
- Treatment with any investigational drug or device within 60 days prior to 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 |
|---|---|---|
| HAVG graft implantationAlso: Human Acellular Vascular GraftPatients will be implanted with a Human Acellular Vascular Graft (HAVG) in the forearm or upper arm (arterial anastomosis to the radial or brachial artery, venous anastomosis to either the brachial, cephalic or very central basilica vein) using standard vascular surgical techniques. The graft will be placed in a straight or curved configuration in the first 10 patients. Loop grafts may be permitted in subsequent patients subject to acceptable graft performance at the interim safety review. Placing the graft across the elbow will be avoided. | Device | HAVG graft |
Primary outcome
HAVG safety & tolerability
Time frame: At each visit within first 6 months after HAVG implantation.
The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be tabulated by visit and overall.
HAVG patency rate
Time frame: At 6 months after HAVG implantation.
Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG.
4 secondary outcomes
PRA response
Time frame: At screening, day 15, 29, 57 and week 12, 26
IgG antibodies
Time frame: At screening, day 15, 29, 57 and week 12, 26
Patency maintenance/restoration
Time frame: At each visit except screening.
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 13 Nov 2024.
- 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.
Shamik Parikh, MD 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 study testing HAVG graft implantation in people with End-stage Renal Disease and Kidney Failure, Chronic, run by Humacyte, Inc. at 3 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 9 inclusion and 23 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 13 Nov 2024. 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 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.
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 safety & tolerability (time frame: At each visit within first 6 months after HAVG implantation.). 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 NCT01744418, 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 13 Nov 2024.