Chronic Kidney Disease
Conditions
Keywords
arteriovenous fistula, AVF, hemodialysis, vascular access, PRT 201, dose escalation, dialysis, fistula, access, vonapanitase, kidney, renal
Brief 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.
Interventions
DRUGPRT-201
Applied topically to AVF during surgery
Sponsors
Proteon Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of at least 18 years. * Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence. * Planned creation of a new AVF.
Exclusion criteria
* Patients for whom this is the only potential site for an AVF. * By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch. * Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent. * Pregnancy, lactation or plans to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein. | 2 & 6 weeks after AVF creation |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. | 3, 6, 9, and 12 months |
Countries
United States
Outcome results
None listed