Renal Insufficiency,ChronicPhase 3BEACHNCT04146012
BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial
A Phase 3 study testing Artegraft® Collagen Vascular Graft™ (Artegraft) in people with Renal Insufficiency,Chronic, run by Artegraft, Inc. at 5 sites in United States.
Trial summary
Bovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis using the Artegraft® Collagen Vascular Graft™. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency,Chronic
- What is being tested?
- Artegraft® Collagen Vascular Graft™ (Artegraft)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Dec 2019to 16 Jun 2020
- Phase
- Phase 3
- 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
- Patients are eligible to be included in the study only if they meet the following criteria:
- Male or Female, 18 years or older
- Diagnosis of End Stage Renal Disease (ESRD) and require vascular access for hemodialysis
- Native [autogenous tissue] AV fistula creation or access is not indicated or non-viable [disadvantaged veins]
- Requiring repair of an existing fistula or conduit, but only if using Artegraft as an interposition placement and the Artegraft is cannulated [not the fistula]. Artegraft must be place in a fresh subcutaneous tunnel. Thigh loop grafts will not be used.
- Able to accommodate vascular graft placement in the upper extremity (i.e., forearm, or upper arm)
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- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
- Able and willing to comply with the study protocol
- Agrees to initiate and maintain hemodialysis treatments
- Life expectancy is > 1 year based on physician assessment
Who cannot join
- Patients are excluded from the trial if any of the following criteria apply:
- High grade central venous stenosis/occlusion
- Breast-feeding, pregnant or planning pregnancy within next 12 months.
- Non-resolved infected existing grafts
- Documented sepsis/bacteremia by blood culture within 4 weeks of implantation.
- History of non-controlled immunodeficiency syndrome, including AIDS/HIV; Active clinically significant immune-mediated disease, not controlled by low-dose maintenance immunosuppression. The diagnosis of HIV alone, provided adequately treated, is not a contraindication for enrolment.
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- Severe liver dysfunction and/or coagulation or bleeding disorders.
- Elevated platelet count > 1 million cells/mm3
- History of heparin-induced thrombocytopenia syndrome (HIT)
- Documented hypercoagulable state
- Currently participating in another investigational drug or device study which may clinically interfere with any endpoints of this trial
- Known hypersensitivity or contraindication to device materials or procedural medications that cannot be adequately managed medically
- History or evidence of severe cardiac disease (NYHA Functional Class III or IV), , myocardial infarction within 6 months of enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina, uncontrolled CHF
- History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e. arterial inflow insufficient to support hemodialysis)
- History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin
- Bleeding diathesis, other than that associated with ESRD
- Scheduled renal transplant within 6 months
- Patients who require chronic anticoagulation except for antiplatelet therapy. Patients currently receiving or who have received within the last month direct thrombin inhibitors, factor Xa inhibitors, or vitamin K antagonists should not be included in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Capital District Renal Physicians
Albany, New York, 12209
City Hospital at White Rock
Dallas, Texas, 75218
Dialysis Access Institute
Orangeburg, South Carolina, 29118
University of California
San Diego, California, 92093
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
About this study
Official title: Bovine Early Access, Compatibility and Hemostasis Post-Market Trial to Evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis Using the Artegraft® Collagen Vascular Graft™
Bovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis using the Artegraft® Collagen Vascular Graft™. The objective of the BEACH Trial is to demonstrate that early access of Artegraft is associated with acceptable rates of successful early access, and acceptable rates of a composite of adverse events, to support a modification of existing device labeling stating that Artegraft is capable of cannulation within 72 hours post implantation.
Read the detailed description
Chronic kidney disease (CKD) is a major health problem that affects approximately 26 million Americans. Many of those suffering CKD will progress to develop end stage renal disease (ESRD) and require lifelong hemodialysis (HD) to filter wastes from their blood. There are nearly 2.5 million patients who receive HD worldwide, and this population is growing at a rate of 8% per year. This projects that the worldwide HD population to reach approximately 3.4 million by the year 2020. There are over 600,000 patients on HD in the US and an estimated 100,000 new cases are reported annually. The interventions required to maintain a person on HD carry a significant financial burden, with costs estimated to be as high as $30 billion annually. Given the increasing epidemic of obesity, diabetes, and heart disease, the burden of ESRD will continue to grow, making new interventions that can improve the social, physical, and financial realities of treating ESRD essential.
A critical factor in the survival of renal dialysis patients is the surgical creation of vascular access. Despite the fistula-first initiative, many patients will start hemodialysis using a central venous catheter (CVC). This increases the risks of associated bloodstream infections, central venous stenosis, and poorer outcomes from subsequent vascular cannulations.
Arteriovenous grafts have advantages compared with central venous catheters for dialysis and guidelines suggest their use as second choice after arteriovenous fistulas. The suggested advantages of grafts over fistulas is the ability to cannulate or access the graft earlier, traditionally 2 weeks for AVG rather than 6 weeks for AVF, and the lower rates of primary failure.
Standard practice with expanded polytetrafluoroethylene (ePTFE) grafts has been to avoid cannulation for 2 weeks following placement, but new generation grafts have been marketed for their early cannulation properties allowing use as an alternative to central venous catheters for prompt access.
The proposed BEACH Trial is a multi-center, prospective clinical trial to evaluate early access of an existing, FDA-approved bovine carotid vascular graft, approved as a general peripheral vascular graft and for hemodialysis. The BEACH Trial is seeking to demonstrate that early access, defined as within 72 hours post implantation, of the Artegraft device results in acceptable clinical outcomes including ability to support dialysis needs thereby obviating the requirement for interim catheter placement or facilitating the removal of an existing catheter with acceptable composite major adverse clinical events (MACE) rate up to 26 weeks (6 months) post implant.
Few vascular products approved in the 1970s have a broad level of acceptance in today's competitive market. Review of the original NDA application for Artegraft as well as the scientific literature revealed no clinical rationale for a waiting period of 14 days (for most access grafts) and 10 days (for Artegraft) before cannulation. The current literature does not seem to support the current guidelines as there is no evidence to suggest that a delay in cannulation of PTFE grafts will improve graft survival and patency.Note also that Artegraft cannot identify any scientific justification in the original NDA for the warning that was placed in the IFU to support the 10-day waiting period before cannulation.
Further, if it is assumed that dialysis is conducted 3 times per week, by allowing cannulation to the Artegraft device in the 72-hour period, only 6 to 10 additional needle punctures are added during the first 10-day period depending on whether cannulation is initiated within 72 hours, respectively. Artegraft believes that this limited number of additional early needle punctures will not significantly affect the safety or efficacy of the graft or the cannulation procedure.
- Conditions
- Renal Insufficiency,Chronic
- Being tested
- Artegraft® Collagen Vascular Graft™ (Artegraft)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artegraft® Collagen Vascular Graft™ (Artegraft)Device
The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
| Study group | Role | What they receive |
|---|---|---|
| Early Access | Active comparator | Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation. Receives: Device: Artegraft® Collagen Vascular Graft™ (Artegraft) |
| Normal Access | Active comparator | Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU. Receives: Device: Artegraft® Collagen Vascular Graft™ (Artegraft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Were Successfully Cannulated.
Early access success, defined by three cannulations, the first one started within 72 hours after implantation, all with minimum dialysis flow rates of 250 ml/min pump flow rate, with a minimum 17-gauge needle.
Measured: less than 72 hours
Patients That Experienced Major Adverse Events
A composite of major adverse clinical events (MACE) including perigraft infection, hemorrhage / hematoma, thrombosis, and pseudoaneurysm within 30 days after first cannulation [Day 0] in the early-access and late-access groups.
Measured: Less than 6 month
Secondary outcomes (3)
Grafts That Were Patent After 30 Days
Patency (Primary, Assisted Primary, and Secondary) at 30 days after first successful cannulation [Day 0], and at 12 and 6 months after implantation in the early-access group and at 30 days post-Day 0 in the late-access group. The late access group will also be assessed for patency at 6 months through a telephone interview or office visit to provide a more robust data set.
Measured: Less than 6 months
Patients That Experience Major Adverse Events
All adverse events will be collected in the early-access group [to 6 months] and the late-access group [to 30 days post Day 0] and summarized by unique event, seriousness, and relationship to device or procedure.
Measured: Less than 6 months
Removal of Catheter After Implantation (For Information Only)
The number of days from graft implant or fistula revision to catheter removal shall be recorded.
Measured: Less than 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start3 Dec 2019
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Why it stopped: Company was sold and clinical trial was suspended then teminated
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.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency,ChronicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Artegraft will follow all study patients enrolled in the proposed clinical trial and that have successful cannulation within 72 hours as defined above, for 6 months. If follow-up is necessary at 1 year after graft implantation, it will be done via phone survey. The late-access group \[\>/= 10 days\] will be followed to 30 days post-first cannulation. If follow-up is necessary at 6 months after graft implantation, it will be done via phone survey. Day 0 is defined as the day of first cannulation, for early-access and late-access groups, to allow full follow-up to at least 30 days for both groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artegraft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmoud Malas, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146012
- Sponsor's protocol ID
- ARTCT.BEACH.001
- Acronym
- BEACH
- Status last verified
- Jun 2023
- First submitted
- 21 Oct 2019
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plans to share individual patient data
Publications
Manns B, Tonelli M, Yilmaz S, Lee H, Laupland K, Klarenbach S, Radkevich V, Murphy B. Establishment and maintenance of vascular access in incident hemodialysis patients: a prospective cost analysis. J Am Soc Nephrol. 2005 Jan;16(1):201-9. doi: 10.1681/ASN.2004050355. Epub 2004 Nov 24.
PubMed 15563567Pastan S, Soucie JM, McClellan WM. Vascular access and increased risk of death among hemodialysis patients. Kidney Int. 2002 Aug;62(2):620-6. doi: 10.1046/j.1523-1755.2002.00460.x.
PubMed 12110026Al Shakarchi J, Inston N. Timing of cannulation of arteriovenous grafts: are we too cautious? Clin Kidney J. 2015 Jun;8(3):290-2. doi: 10.1093/ckj/sfu146. Epub 2015 Jan 20.
PubMed 26034590US Renal Data System, Annual Data Report: Atlas of Chronic Kidney Disease and End Stage Renal Disease in the United States, Bethesda MD, National Institutes of Health, National Institute of Diabetes and Kidney Diseases, 2009
Fresenius Medical Care : Fresenious Medical Care Annual Report 2011 - Dialysis Market, Bad Homburg, Germany, Freesenious Medical Care, 2011
US Renal Data System: 2012 Annual Data Report : Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2012
US Renal Data System: 2014 Annual Data Report : Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2014
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bovine Early Access, Compatibility and Hemostasis Post-Market Trial to Evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis Using the Artegraft® Collagen Vascular Graft™
- ClinicalTrials.gov ID
- NCT04146012
- Acronym / sponsor ID
- BEACH / ARTCT.BEACH.001
- Conditions
- Renal Insufficiency,Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company was sold and clinical trial was suspended then teminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Artegraft, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Posted 29 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis using the Artegraft® Collagen Vascular Graft™. The objective of the BEACH Trial is to demonstrate that early access of Artegraft is associated with acceptable rates of successful early access, and acceptable rates of a composite of adverse events, to support a modification of existing device labeling stating that Artegraft is capable of cannulation within 72 hours post implantation.
Detailed description
Chronic kidney disease (CKD) is a major health problem that affects approximately 26 million Americans. Many of those suffering CKD will progress to develop end stage renal disease (ESRD) and require lifelong hemodialysis (HD) to filter wastes from their blood. There are nearly 2.5 million patients who receive HD worldwide, and this population is growing at a rate of 8% per year. This projects that the worldwide HD population to reach approximately 3.4 million by the year 2020. There are over 600,000 patients on HD in the US and an estimated 100,000 new cases are reported annually. The interventions required to maintain a person on HD carry a significant financial burden, with costs estimated to be as high as $30 billion annually. Given the increasing epidemic of obesity, diabetes, and heart disease, the burden of ESRD will continue to grow, making new interventions that can improve the social, physical, and financial realities of treating ESRD essential.
A critical factor in the survival of renal dialysis patients is the surgical creation of vascular access. Despite the fistula-first initiative, many patients will start hemodialysis using a central venous catheter (CVC). This increases the risks of associated bloodstream infections, central venous stenosis, and poorer outcomes from subsequent vascular cannulations.
Arteriovenous grafts have advantages compared with central venous catheters for dialysis and guidelines suggest their use as second choice after arteriovenous fistulas. The suggested advantages of grafts over fistulas is the ability to cannulate or access the graft earlier, traditionally 2 weeks for AVG rather than 6 weeks for AVF, and the lower rates of primary failure.
Standard practice with expanded polytetrafluoroethylene (ePTFE) grafts has been to avoid cannulation for 2 weeks following placement, but new generation grafts have been marketed for their early cannulation properties allowing use as an alternative to central venous catheters for prompt access.
The proposed BEACH Trial is a multi-center, prospective clinical trial to evaluate early access of an existing, FDA-approved bovine carotid vascular graft, approved as a general peripheral vascular graft and for hemodialysis. The BEACH Trial is seeking to demonstrate that early access, defined as within 72 hours post implantation, of the Artegraft device results in acceptable clinical outcomes including ability to support dialysis needs thereby obviating the requirement for interim catheter placement or facilitating the removal of an existing catheter with acceptable composite major adverse clinical events (MACE) rate up to 26 weeks (6 months) post implant.
Few vascular products approved in the 1970s have a broad level of acceptance in today's competitive market. Review of the original NDA application for Artegraft as well as the scientific literature revealed no clinical rationale for a waiting period of 14 days (for most access grafts) and 10 days (for Artegraft) before cannulation. The current literature does not seem to support the current guidelines as there is no evidence to suggest that a delay in cannulation of PTFE grafts will improve graft survival and patency.Note also that Artegraft cannot identify any scientific justification in the original NDA for the warning that was placed in the IFU to support the 10-day waiting period before cannulation.
Further, if it is assumed that dialysis is conducted 3 times per week, by allowing cannulation to the Artegraft device in the 72-hour period, only 6 to 10 additional needle punctures are added during the first 10-day period depending on whether cannulation is initiated within 72 hours, respectively. Artegraft believes that this limited number of additional early needle punctures will not significantly affect the safety or efficacy of the graft or the cannulation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Artegraft will follow all study patients enrolled in the proposed clinical trial and that have successful cannulation within 72 hours as defined above, for 6 months. If follow-up is necessary at 1 year after graft implantation, it will be done via phone survey. The late-access group [>/= 10 days] will be followed to 30 days post-first cannulation. If follow-up is necessary at 6 months after graft implantation, it will be done via phone survey. Day 0 is defined as the day of first cannulation, for early-access and late-access groups, to allow full follow-up to at least 30 days for both groups.
| Arm | Type | Receives |
|---|---|---|
| Early Access | Active comparator | Device: Artegraft® Collagen Vascular Graft™ (Artegraft)Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation. |
| Normal Access | Active comparator | Device: Artegraft® Collagen Vascular Graft™ (Artegraft)Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients are eligible to be included in the study only if they meet the following criteria:
- Male or Female, 18 years or older
- Diagnosis of End Stage Renal Disease (ESRD) and require vascular access for hemodialysis
- Native [autogenous tissue] AV fistula creation or access is not indicated or non-viable [disadvantaged veins]
- Requiring repair of an existing fistula or conduit, but only if using Artegraft as an interposition placement and the Artegraft is cannulated [not the fistula]. Artegraft must be place in a fresh subcutaneous tunnel. Thigh loop grafts will not be used.
Key exclusion criteria (18 listed)
- High grade central venous stenosis/occlusion
- Breast-feeding, pregnant or planning pregnancy within next 12 months.
- Non-resolved infected existing grafts
- Documented sepsis/bacteremia by blood culture within 4 weeks of implantation.
- History of non-controlled immunodeficiency syndrome, including AIDS/HIV; Active clinically significant immune-mediated disease, not controlled by low-dose maintenance immunosuppression. The diagnosis of HIV alone, provided adequately treated, is not a contraindication for enrolment.
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 |
|---|---|---|
| Artegraft® Collagen Vascular Graft™ (Artegraft)The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft. | Device | Early Access, Normal Access |
Primary outcome
Number of Participants That Were Successfully Cannulated.
Time frame: less than 72 hours
Early access success, defined by three cannulations, the first one started within 72 hours after implantation, all with minimum dialysis flow rates of 250 ml/min pump flow rate, with a minimum 17-gauge needle.
Patients That Experienced Major Adverse Events
Time frame: Less than 6 month
A composite of major adverse clinical events (MACE) including perigraft infection, hemorrhage / hematoma, thrombosis, and pseudoaneurysm within 30 days after first cannulation [Day 0] in the early-access and late-access groups.
3 secondary outcomes
Grafts That Were Patent After 30 Days
Time frame: Less than 6 months
Patients That Experience Major Adverse Events
Time frame: Less than 6 months
Removal of Catheter After Implantation (For Information Only)
Time frame: Less than 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15563567Manns B, Tonelli M, Yilmaz S, Lee H, Laupland K, Klarenbach S, Radkevich V, Murphy B. Establishment and maintenance of vascular access in incident hemodialysis patients: a prospective cost analysis. J Am Soc Nephrol. 2005 Jan;16(1):201-9. doi: 10.1681/ASN.2004050355. Epub 2004 Nov 24.
- Background: PubMed 12110026Pastan S, Soucie JM, McClellan WM. Vascular access and increased risk of death among hemodialysis patients. Kidney Int. 2002 Aug;62(2):620-6. doi: 10.1046/j.1523-1755.2002.00460.x.
- Background: PubMed 26034590Al Shakarchi J, Inston N. Timing of cannulation of arteriovenous grafts: are we too cautious? Clin Kidney J. 2015 Jun;8(3):290-2. doi: 10.1093/ckj/sfu146. Epub 2015 Jan 20.
- BackgroundUS Renal Data System, Annual Data Report: Atlas of Chronic Kidney Disease and End Stage Renal Disease in the United States, Bethesda MD, National Institutes of Health, National Institute of Diabetes and Kidney Diseases, 2009
- BackgroundFresenius Medical Care : Fresenious Medical Care Annual Report 2011 - Dialysis Market, Bad Homburg, Germany, Freesenious Medical Care, 2011
- BackgroundUS Renal Data System: 2012 Annual Data Report : Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2012
- BackgroundUS Renal Data System: 2014 Annual Data Report : Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2014
- Individual participant dataSharing planned: No. No plans to share individual patient data
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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.
Mahmoud Malas, MD principal investigator
University of California, San Diego
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artegraft® Collagen Vascular Graft™ (Artegraft) in people with Renal Insufficiency,Chronic, run by Artegraft, Inc. at 5 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 10 inclusion and 18 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: stopped early, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 29 Jun 2023). 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?
Number of Participants That Were Successfully Cannulated. (time frame: less than 72 hours). 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 NCT04146012, which also lists 7 linked publications.
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 29 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.