Trials / Completed
CompletedNCT00679991
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Proteon Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRT-201 | Applied topically to AVF during surgery |
| DRUG | PRT-201 | Dose escalation study. Drug/placebo administered at the time of fistula creation |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2008-05-19
- Last updated
- 2015-04-30
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00679991. Inclusion in this directory is not an endorsement.