Trials / Completed
CompletedNCT01001351
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 89 (actual)
- Sponsor
- Proteon Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRT-201 | Applied topically during surgery. |
| DRUG | Placebo | Applied topically during surgery |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2009-10-26
- Last updated
- 2015-04-30
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01001351. Inclusion in this directory is not an endorsement.