A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
Public ClinicalTrials.gov record NCT01001351. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Graft Creation in Patients With Chronic Kidney Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.
Study identification
- NCT ID
- NCT01001351
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2009
- Primary completion
- Oct 31, 2012
- Completion
- Oct 31, 2012
- Last update posted
- Apr 29, 2015
2009 – 2012
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ladenheim Dialysis Access Center | Fresno | California | 93710 | — |
| California Institute of Renal Research | San Diego | California | 92123 | — |
| Washington Hospital/Medstar Research | Washington D.C. | District of Columbia | 20010 | — |
| Indiana/Ohio Heart | Fort Wayne | Indiana | 46804 | — |
| Indiana University/Purdue University | Indianapolis | Indiana | 46202 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Vascular Specialty Center | Baton Rouge | Louisiana | 70809 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Massachusetts | Worcester | Massachusetts | 01655 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Greenville Memorial Hospital | Greenville | South Carolina | 29615 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| Peripheral Vascular Associates | San Antonio | Texas | 78205 | — |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01001351, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2015 · Synced Sep 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01001351 live on ClinicalTrials.gov.