A Phase 1/2 interventional study of PRT-201 and Placebo in Chronic Kidney Disease, sponsored by Proteon Therapeutics. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-30.
Sponsored by Proteon Therapeutics · Phase 1/2, Interventional, and Treatment
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.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 89 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Proteon Therapeutics is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Drug: Placebo
Drug: PRT-201
Applied topically during surgery.
Applied topically during surgery
To assess the safety of a single topical dose of PRT-201.
Time frame: Day of AVG creation and 4 weeks After surgery.
Primary graft patency
Time frame: 3, 6, 9 and 12 months after AVG creation.
Secondary graft patency.
Time frame: 3, 6, 9 and 12 months after AVG creation.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholesterol-binding protein
Renal Insufficiency, Chronic →
Proteon Therapeutics