A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414841
• Other study ID #: PRT-201-320
• Status: Completed
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2019
• Source: Proteon Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether vonapanitase when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 696
• Est. completion date: May 1, 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Age of at least 18 years.

2. Life expectancy of at least 6 months.

3. Diagnosis of CKD.

4. Planned creation of a new radiocephalic AVF (revision of an existing AVF is not eligible).

5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team.

6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device.

Exclusion Criteria:

1. 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 or squamous cell skin cancer, or any cancer in situ.

2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.

3. Previous treatment with vonapanitase (PRT-201).

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Vonapanitase

• Placebo

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	London Health Science Center	London	Ontario
Canada	McGill University Health Centre- Royal Victoria Hospital	Montreal	Quebec
Canada	University Health Network Toronto General Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	Cardiothoracis and Vascular Surgeons	Austin	Texas
United States	Lake Washington Vascular Center	Bellevue	Washington
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Lutheran Hospital Network of Indiana	Fort Wayne	Indiana
United States	Greenwood Leflore Hospital	Greenwood	Mississippi
United States	Baylor College of Medicine	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	The University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Knoxville Kidney Center	Knoxville	Tennessee
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	VA Medical Center Long Beach	Long Beach	California
United States	Keck University Hospital at USC	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin School of Medicine and PH	Madison	Wisconsin
United States	Tulane University	New Orleans	Louisiana
United States	New York Presbyterian Hospital-Weill Cornell Medical Center	New York	New York
United States	SC Nephrology and Hypertension Center, Inc.	Orangeburg	South Carolina
United States	RenalCare Associates, S.C.	Peoria	Illinois
United States	AKDHC Medical Research Services, LLC	Phoenix	Arizona
United States	VA Pittsburg Healthcare System	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	California Institute of Renal Research	San Diego	California
United States	Kaiser Permanente	San Diego	California
United States	Kaiser Permanente Northern California	San Francisco	California
United States	AKDHC Medical Research Services, LLc	Tucson	Arizona
United States	Banner University Medical Center Tucson	Tucson	Arizona
United States	Wake Forest	Winston-Salem	North Carolina
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Proteon Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier Estimate of Secondary AVF Patency	Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)	Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Primary	Number of Participants With AVF Use for Hemodialysis	AVF use for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use.	Assessed at up to 12 Months