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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 is a Phase 1 study that has completed, run by Proteon Therapeutics. The registered enrollment target is 89 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01001351
The ClinicalTrials.gov registry entry for NCT01001351 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Proteon Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01001351 reports 0 study locations.
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.
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