A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
- Registration Number
- NCT00679991
- Lead Sponsor
- Proteon Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRT-201 PRT-201 - 2 PRT-201 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. 3, 6, 9, and 12 months
Trial Locations
- Locations (11)
Clarian Health Partners/Indiana University/Purdue University
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Western New England Renal & Transplant Associates
🇺🇸Springfield, Massachusetts, United States
Washington University in St. Louis
🇺🇸St. Louis, Missouri, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Scroll for more (1 remaining)Clarian Health Partners/Indiana University/Purdue University🇺🇸Indianapolis, Indiana, United States