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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01305824
Other study ID # PRT-201-201
Secondary ID
Status Completed
Phase Phase 2
First received February 16, 2011
Last updated April 8, 2015
Start date March 2011
Est. completion date November 2012

Study information

Verified date April 2015
Source Proteon Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age of at least 18 years.

2. Life expectancy of at least 6 months.

3. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.

4. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.

Exclusion Criteria:

1. History or presence of an arterial aneurysm.

2. 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.

3. 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.

4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
PRT-201
PRT-201 10 micrograms administered at the time of AVF creation.
Placebo
Placebo administered at the time of AVF creation.
PRT-201
PRT-201 30 micrograms administered at the time of AVF creation.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Proteon Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hye RJ, Peden EK, O'Connor TP, Browne BJ, Dixon BS, Schanzer AS, Jensik SC, Dember LM, Jaff MR, Burke SK. Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease. J Vasc Surg. 2014 Aug;60(2):454-461.e1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary AVF patency. 12 months after AVF creation Yes
Primary Number of participants with adverse events as a measure of safety and tolerability of PRT-201. 12 months after AVF creation. Yes
Secondary Secondary Fistula Patency 12 months after AVF creation Yes
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