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PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRT-201 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRT-201 | Drug | Applied topically to AVF during surgery |
| |
| PRT-201 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein. | 2 & 6 weeks after AVF creation |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. | 3, 6, 9, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clarian Health Partners/Indiana University/Purdue University | Indianapolis | Indiana | 46202 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23172172 | Result | Peden EK, Leeser DB, Dixon BS, El-Khatib MT, Roy-Chaudhury P, Lawson JH, Menard MT, Dember LM, Glickman MH, Gustafson PN, Blair AT, Magill M, Franano FN, Burke SK. A multi-center, dose-escalation study of human type I pancreatic elastase (PRT-201) administered after arteriovenous fistula creation. J Vasc Access. 2013 Apr-Jun;14(2):143-51. doi: 10.5301/jva.5000125. Epub 2012 Nov 20. |
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| Drug |
Dose escalation study. Drug/placebo administered at the time of fistula creation |
|
| University of Iowa Hospitals and Clinics |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Western New England Renal & Transplant Associates | Springfield | Massachusetts | 01104 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | 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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