A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients (NCT00679991) | Clinical Trial Compass
CompletedPhase 1/2
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
United States66 participantsStarted 2008-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.