A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110901
• Other study ID #: PRT-201-310
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: December 2018

Study information

• Verified date: June 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 PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 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 PRT-201 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: 349
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• 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 Chronic Kidney Disease (CKD).

4. Planned creation of a new radiocephalic arteriovenous fistula (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).

7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) 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 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:
• PRT-201

• Placebo

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Maryland	Baltimore	Maryland
United States	Lake Washington Vascular Center	Bellevue	Washington
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Rush Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	University of Maryland Shore Medical Center at Easton	Easton	Maryland
United States	Lutheran Hospital Network of Indiana	Fort Wayne	Indiana
United States	The Methodist Hospital	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Alliance Research Center	Laguna Hills	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	Tulane University	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	Renal Care Associates	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	W.G. Hefner VA Medical Center	Salisbury	North Carolina
United States	California Institute of Renal Research	San Diego	California
United States	Kaiser Permanente Medical Center	San Diego	California
United States	UCSF Division of Vascular & Endovascular Surgery	San Francisco	California
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana
United States	AKDHC Medical Research Services, LLc	Tucson	Arizona
United States	The University of Oklahoma College of Medicine	Tulsa	Oklahoma
United States	Wake Forest	Winston-Salem	North Carolina
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Proteon Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Unassisted AVF Maturation by Ultrasound	AVF maturation is defined as average cephalic vein lumen diameter >= 4 mm and an outflow vein volume blood flow >= 500 mL/min by ultrasound without prior primary unassisted patency loss.	Assessed 3 months after AVF creation
Other	Number of Participants With Unassisted AVF Use for Hemodialysis	Unassisted AVF use for hemodialysis is defined as continuous use of the AVF for hemodialysis without prior primary unassisted patency loss. Use of the AVF 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 was not initiated at least 90 days prior to the last visit. 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 by the rules described above have insufficient data to determine use for hemodialysis and will be categorized as having indeterminate use.	Assessed at 12 months
Primary	Time to AVF Primary Unassisted Patency	Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.	Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year
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 until AVF abandonment (secondary patency), assessed up to 1 year