Status:
COMPLETED
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
Lead Sponsor:
Proteon Therapeutics
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 pate...
Eligibility Criteria
Inclusion
- Age of at least 18 years.
- Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.
- Planned creation of a new upper extremity AVG or "jump" graft
Exclusion
- Patients for whom this is the only potential site for an upper extremity vascular access.
- Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.
- On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.
- History or presence of an arterial aneurysm.
- Previous treatment with PRT-201.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01001351
Start Date
September 1 2009
End Date
November 1 2012
Last Update
April 30 2015
Active Locations (16)
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1
Ladenheim Dialysis Access Center
Fresno, California, United States, 93710
2
California Institute of Renal Research
San Diego, California, United States, 92123
3
Washington Hospital/Medstar Research
Washington D.C., District of Columbia, United States, 20010
4
Indiana/Ohio Heart
Fort Wayne, Indiana, United States, 46804