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The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRT 201 (10 micrograms) | Active Comparator |
| |
| Placebo | Placebo Comparator |
| |
| PRT-201 (30 micrograms) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRT-201 | Drug | PRT-201 10 micrograms administered at the time of AVF creation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary AVF patency. | 12 months after AVF creation | |
| Number of participants with adverse events as a measure of safety and tolerability of PRT-201. | 12 months after AVF creation. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Fistula Patency | 12 months after AVF creation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Institute of Renal Research | San Diego | California | 92123 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24684771 | Result | Hye RJ, Peden EK, O'Connor TP, Browne BJ, Dixon BS, Schanzer AS, Jensik SC, Dember LM, Jaff MR, Burke SK. Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease. J Vasc Surg. 2014 Aug;60(2):454-461.e1. doi: 10.1016/j.jvs.2014.02.037. Epub 2014 Mar 27. |
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| Placebo |
| Drug |
Placebo administered at the time of AVF creation. |
|
| PRT-201 | Drug | PRT-201 30 micrograms administered at the time of AVF creation. |
|
| San Diego |
| California |
| United States |
| UCSF | San Francisco | California | United States |
| Rush Medical Center | Chicago | Illinois | United States |
| Renal Care Associates | Peoria | Illinois | United States |
| Indiana Ohio Heart | Fort Wayne | Indiana | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Louisville | Louisville | Kentucky | United States |
| Vascular Specialty Center | Baton Rouge | Louisiana | United States |
| Beth Israel Deconness Hospital | Boston | Massachusetts | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | United States |
| UMASS Medical Center | Worcester | Massachusetts | United States |
| St Clair Specialty Physicians | Detroit | Michigan | United States |
| Thoracic & Cardiovascular Healthcare Foundation | Lansing | Michigan | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Montefiore Medical Center | The Bronx | New York | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Legacy Oregon Surgical | Portland | Oregon | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Sentara Medical Group | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D001164 | Arteriovenous Fistula |
| D005402 | 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 |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| C017130 | cholesterol-binding protein |
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