A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT00679991

Run by

Proteon Therapeutics

People needed

66

Starts

2008-11-01

Expected to finish

2011-07-01

Last updated by the study team

2015-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Sentara Medical Group — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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