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This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRT-201 | Active Comparator | PRT-201 administered at the time of radiocephalic fistula creation |
|
| Placebo | Placebo Comparator | Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRT-201 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to AVF Primary Unassisted Patency | Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency. | Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year |
| Kaplan-Meier Estimate of Secondary AVF Patency | Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency) | Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unassisted AVF Maturation by Ultrasound | AVF maturation is defined as average cephalic vein lumen diameter >= 4 mm and an outflow vein volume blood flow >= 500 mL/min by ultrasound without prior primary unassisted patency loss. | Assessed 3 months after AVF creation |
| Number of Participants With Unassisted AVF Use for Hemodialysis |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| AKDHC Medical Research Services , LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38825327 | Derived | Heindel P, Fitzgibbon JJ, Secemsky EA, Belkin M, Ozaki CK, Hussain MA. Evaluating the effectiveness of systemic heparin during arteriovenous fistula creation by emulating a target trial. Am J Epidemiol. 2025 Mar 4;194(3):651-658. doi: 10.1093/aje/kwae098. | |
| 36567000 | Derived | Heindel P, Fitzgibbon JJ, Feliz JD, Hentschel DM, Burke SK, Al-Omran M, Bhatt DL, Belkin M, Ozaki CK, Hussain MA. Evaluating national guideline concordance of recurrent interventions after radiocephalic arteriovenous fistula creation. J Vasc Surg. 2023 Apr;77(4):1206-1215.e2. doi: 10.1016/j.jvs.2022.12.017. Epub 2022 Dec 22. |
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Participants were excluded from participation if they did not have a radiocephalic AVF created at the time of surgery.
349 patients signed informed consent; 313 patients were randomized; 311 were treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Vonapanitase | Vonapanitase administered at the time of radiocephalic fistula creation |
| FG001 | Placebo | Placebo administered at the time of radiocephalic fistula creation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
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Unassisted AVF use for hemodialysis is defined as continuous use of the AVF for hemodialysis without prior primary unassisted patency loss. Use of the AVF for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis was not initiated at least 90 days prior to the last visit. Non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF by the rules described above have insufficient data to determine use for hemodialysis and will be categorized as having indeterminate use. |
| Assessed at 12 months |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| AKDHC Medical Research Services, LLc | Tucson | Arizona | 85719 | United States |
| Alliance Research Center | Laguna Hills | California | 92653 | United States |
| VA Medical Center Long Beach | Long Beach | California | 90822 | United States |
| Keck University Hospital at USC | Los Angeles | California | 90033 | United States |
| Kaiser Permanente Medical Center | San Diego | California | 92120 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| UCSF Division of Vascular & Endovascular Surgery | San Francisco | California | 94143 | United States |
| Rush Medical Center | Chicago | Illinois | 60612 | United States |
| Renal Care Associates | Peoria | Illinois | 61603 | United States |
| Lutheran Hospital Network of Indiana | Fort Wayne | Indiana | 46804 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Louisiana State University Health Sciences Center | Shreveport | Louisiana | 71130 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| University of Maryland Shore Medical Center at Easton | Easton | Maryland | 21601 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02482 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| W.G. Hefner VA Medical Center | Salisbury | North Carolina | 28144 | United States |
| Wake Forest | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| The University of Oklahoma College of Medicine | Tulsa | Oklahoma | 74104 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| VA Pittsburg Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Lake Washington Vascular Center | Bellevue | Washington | 98004 | United States |
| 30683197 | Derived | Bleyer AJ, Scavo VA, Wilson SE, Browne BJ, Ferris BL, Ozaki CK, Lee T, Peden EK, Dixon BS, Mishler R, O'Connor TP, Kidd K, Burke SK; PATENCY-1 Investigators. A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis. J Vasc Surg. 2019 Feb;69(2):507-515. doi: 10.1016/j.jvs.2018.04.068. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vonapanitase | Single application administered over 10 minutes at the time of fistula creation. |
| BG001 | Placebo | Single application administered over 10 minutes at the time of fistula creation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to AVF Primary Unassisted Patency | Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency. | Full analysis set includes any patient who was randomized. | Posted | Median | 95% Confidence Interval | Days | Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Kaplan-Meier Estimate of Secondary AVF Patency | Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency) | Full analysis set included all patients who were randomized | Posted | Median | 95% Confidence Interval | days | Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Unassisted AVF Maturation by Ultrasound | AVF maturation is defined as average cephalic vein lumen diameter >= 4 mm and an outflow vein volume blood flow >= 500 mL/min by ultrasound without prior primary unassisted patency loss. | Full analysis set includes any patient who was randomized | Posted | Count of Participants | Participants | Assessed 3 months after AVF creation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Unassisted AVF Use for Hemodialysis | Unassisted AVF use for hemodialysis is defined as continuous use of the AVF for hemodialysis without prior primary unassisted patency loss. Use of the AVF for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis was not initiated at least 90 days prior to the last visit. Non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF by the rules described above have insufficient data to determine use for hemodialysis and will be categorized as having indeterminate use. | Patients with unassisted use or non-use of their AVF for hemodialysis. Patients with indeterminate use of their AVF were excluded. | Posted | Count of Participants | Participants | Assessed at 12 months |
|
All adverse events through Week 6 were collected. Week 6-Month 12 only AEs associated with the AVF extremity were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vonapanitase | Vonapanitase administered at the time of radiocephalic fistula creation Vonapanitase | 7 | 209 | 29 | 209 | 149 | 209 |
| EG001 | Placebo | Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient. Placebo | 4 | 102 | 15 | 102 | 84 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulseless Electrical Activity | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Arthritis Bacterial | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arteriovenous Fistula Thrombosis | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoxic-Ischaemic Encephalopathy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Metabolic Encephalopathy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
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| Renal Failure Chronic | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haemoptyis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diabetic Foot | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
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| Steal Syndrome | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
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| Vascular Stenosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vascular Stenosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Burke, MD | Proteon Therapeutics, Inc | 781-890-0102 | Clinical@ProteonTx.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| C017130 | cholesterol-binding protein |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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