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NCT01001351 · ClinicalTrials.gov registry record · Phase 1
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
A Phase 1 study, sponsored by Proteon Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT01001351: Completed Phase 1 study, sponsored by Proteon Therapeutics.
NCT01001351 is a Phase 1 study that has completed, run by Proteon Therapeutics. The registered enrollment target is 89 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01001351, a Phase 1 study, has completed, sponsored by Proteon Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG PRT-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01001351 record still lists
NCT01001351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01001351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01001351 about?
NCT01001351 is a clinical study titled "A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease". 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 ...
What is the current status of trial NCT01001351?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2009-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01001351?
The interventions under investigation include: Placebo (DRUG), PRT-201 (DRUG).
Who is sponsoring clinical trial NCT01001351?
This trial is sponsored by Proteon Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01001351's enrollment target sits among peer trials
89 649th of 2000 higher than 1,351 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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