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

Phase 2

Completed

Conditions: Chronic Kidney Disease

Interventions: Drug: PRT-201
Drug: Placebo

Registration Number: NCT01305824

Lead Sponsor: Proteon Therapeutics

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRT 201 (10 micrograms)	PRT-201	-
PRT-201 (30 micrograms)	PRT-201	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability of PRT-201.	12 months after AVF creation.
Primary AVF patency.	12 months after AVF creation

Secondary Outcome Measures

Name	Time	Method
Secondary Fistula Patency	12 months after AVF creation

Trial Locations

Locations (23): UMASS Medical Center
🇺🇸
Worcester, Massachusetts, United States
Thoracic & Cardiovascular Healthcare Foundation
🇺🇸
Lansing, Michigan, United States
Rush Medical Center
🇺🇸
Chicago, Illinois, United States
Beth Israel Deconness Hospital
🇺🇸
Boston, Massachusetts, United States
Renal Care Associates
🇺🇸
Peoria, Illinois, United States
Indiana Ohio Heart
🇺🇸
Fort Wayne, Indiana, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Weill Cornell Medical College
🇺🇸
New York, New York, United States
Lehigh Valley Hospital
🇺🇸
Allentown, Pennsylvania, United States
Sentara Medical Group
🇺🇸
Norfolk, Virginia, United States
Legacy Oregon Surgical
🇺🇸
Portland, Oregon, United States
Vascular Specialty Center
🇺🇸
Baton Rouge, Louisiana, United States
Kaiser Permanente
🇺🇸
San Diego, California, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
St Clair Specialty Physicians
🇺🇸
Detroit, Michigan, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
The Methodist Hospital
🇺🇸
Houston, Texas, United States
UCSF
🇺🇸
San Francisco, California, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
California Institute of Renal Research
🇺🇸
San Diego, California, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States