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This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase 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 vonapanitase 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 |
|---|---|---|---|
| Vonapanitase | Active Comparator | Vonapanitase administered at the time of radiocephalic fistula creation |
|
| Placebo | Placebo Comparator | Placebo administered at the time of radiocephalic fistula creation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonapanitase | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 to AVF abandonment (secondary patency), assessed up to 1 year. |
| Number of Participants With AVF Use for Hemodialysis | AVF use 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 has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, 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 have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use. | Assessed at up to 12 Months |
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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 if they did not have a radiocephalic fistula created at the time of surgery
696 patients signed informed consent; 613 patients were randomized; 603 were treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Vonapanitase | Vonapanitase administered at the time of radiocephalic fistula creation vonapanitase |
| FG001 | Placebo | Placebo administered at the time of radiocephalic fistula creation Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2018 |
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| Drug |
|
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Banner University Medical Center Tucson | Tucson | Arizona | 85724 | United States |
| AKDHC Medical Research Services, LLc | Tucson | Arizona | 85745 | United States |
| VA Loma Linda Healthcare System | Loma Linda | California | 92357 | 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 | San Diego | California | 92120 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| Kaiser Permanente Northern California | San Francisco | California | 94118 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| RenalCare Associates, S.C. | Peoria | Illinois | 61603 | United States |
| Lutheran Hospital Network of Indiana | Fort Wayne | Indiana | 46804 | United States |
| The 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 |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | United States |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Greenwood Leflore Hospital | Greenwood | Mississippi | 38930 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| New York Presbyterian Hospital-Weill Cornell Medical Center | New York | New York | 10065 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| VA Pittsburg Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
| SC Nephrology and Hypertension Center, Inc. | Orangeburg | South Carolina | 29118 | United States |
| Knoxville Kidney Center | Knoxville | Tennessee | 37923 | United States |
| Cardiothoracis and Vascular Surgeons | Austin | Texas | 78756 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Lake Washington Vascular Center | Bellevue | Washington | 98004 | United States |
| University of Wisconsin School of Medicine and PH | Madison | Wisconsin | 53792 | United States |
| University of Alberta | Edmonton | Alberta | T6G2B7 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| London Health Science Center | London | Ontario | N6A 5W9 | Canada |
| University Health Network Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| McGill University Health Centre- Royal Victoria Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| 33482699 | Derived | Peden EK, Lucas JF 3rd, Browne BJ, Settle SM, Scavo VA, Bleyer AJ, Ozaki CK, Teruya TH, Wilson SE, Mishler RE, Ferris BL, Hendon KS, Moist L, Dixon BS, Wong MD, Magill M, Lindow F, Gustafson P, Burke SK; PATENCY-2 Investigators. PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency. J Vasc Access. 2022 Mar;23(2):265-274. doi: 10.1177/1129729820985626. Epub 2021 Jan 22. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vonapanitase | Vonapanitase administered at the time of radiocephalic fistula creation |
| BG001 | Placebo | Placebo administered at the time of radiocephalic 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 |
| ||||||||||||||||||
| 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 | Kaplan-Meier Estimate of Secondary AVF Patency | Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency) | Full analysis set includes all 613 patients who were randomized | Posted | Median | 95% Confidence Interval | Days | Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year. |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With AVF Use for Hemodialysis | AVF use 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 has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, 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 have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use. | Patients having use or non-use of their AVF. Patients with indeterminate use of their AVF were excluded. | Posted | Count of Participants | Participants | Assessed at up to 12 Months |
|
|
All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
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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 | 17 | 399 | 48 | 399 | 247 | 399 |
| EG001 | Placebo | Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient. | 14 | 204 | 30 | 204 | 135 | 204 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulseless Electrical Activity | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Venous Thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Steal Syndrome | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Toe Surgery | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arteriovenous Fistula Thrombosis | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary Tuberculosis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Device Kink | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Collateral Circulation | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vascular Stenosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Unknown Cause of Death | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Post Procedural Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Circulatory Collapse | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local Swelling | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arteriovenous Fistula Thrombosis | Injury, poisoning and procedural complications | 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 |
| May 24, 2019 |
| Prot_SAP_000.pdf |
| 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 |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Participants |
|
|
|