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

Chronic Kidney Disease Clinical Trial

Official title:

Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305824
• Other study ID #: PRT-201-201
• 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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Disease
• Fistula
• Kidney Diseases
• Renal Insufficiency, Chronic

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