A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.

Key facts

Study ID

NCT01305824

Run by

Proteon Therapeutics

People needed

151

Starts

2011-03-01

Expected to finish

2012-11-01

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.
• Life expectancy of at least 6 months.
• Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
• Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.

You may not qualify if…

• History or presence of an arterial aneurysm.
• Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell cancer, squamous cell skin cancer, or any cancer in situ.
• Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.
• Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.

Where it is running

• California Institute of Renal Research — San Diego, California, United States
• Kaiser Permanente — San Diego, California, United States
• UCSF — San Francisco, California, United States
• Rush Medical Center — Chicago, Illinois, United States
• Renal Care Associates — Peoria, Illinois, United States
• Indiana Ohio Heart — Fort Wayne, Indiana, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Vascular Specialty Center — Baton Rouge, Louisiana, United States
• Beth Israel Deconness Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• UMASS Medical Center — Worcester, Massachusetts, United States
• St Clair Specialty Physicians — Detroit, Michigan, United States
• Thoracic & Cardiovascular Healthcare Foundation — Lansing, Michigan, United States
• Weill Cornell Medical College — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Legacy Oregon Surgical — Portland, Oregon, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The Methodist Hospital — Houston, Texas, United States
• Sentara Medical Group — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.