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

NCT ID: NCT02414841

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 696 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-05-01

Brief 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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vonapanitase

Vonapanitase administered at the time of radiocephalic fistula creation

Group Type: ACTIVE_COMPARATOR

Vonapanitase

Intervention Type: DRUG

Placebo

Placebo administered at the time of radiocephalic fistula creation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Vonapanitase

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

PRT-201

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Proteon Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

AKDHC Medical Research Services, LLC

Phoenix, Arizona, United States

Banner University Medical Center Tucson

Tucson, Arizona, United States

AKDHC Medical Research Services, LLc

Tucson, Arizona, 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

Kaiser Permanente

San Diego, California, United States

California Institute of Renal Research

San Diego, California, United States

Kaiser Permanente Northern California

San Francisco, California, United States

University of Chicago

Chicago, Illinois, United States

RenalCare Associates, S.C.

Peoria, Illinois, United States

Lutheran Hospital Network of Indiana

Fort Wayne, Indiana, United States

The University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Louisville

Louisville, Kentucky, United States

Tulane University

New Orleans, Louisiana, United States

Maine Medical Center

Portland, Maine, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Greenwood Leflore Hospital

Greenwood, Mississippi, United States

Saint Luke's Hospital

Kansas City, Missouri, United States

New York Presbyterian Hospital-Weill Cornell Medical Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Wake Forest

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

VA Pittsburg Healthcare System

Pittsburgh, Pennsylvania, United States

SC Nephrology and Hypertension Center, Inc.

Orangeburg, South Carolina, United States

Knoxville Kidney Center

Knoxville, Tennessee, United States

Cardiothoracis and Vascular Surgeons

Austin, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

The Methodist Hospital

Houston, Texas, United States

Lake Washington Vascular Center

Bellevue, Washington, United States

University of Wisconsin School of Medicine and PH

Madison, Wisconsin, United States

University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

London Health Science Center

London, Ontario, Canada

University Health Network Toronto General Hospital

Toronto, Ontario, Canada

McGill University Health Centre- Royal Victoria Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

References

Heindel P, Fitzgibbon JJ, Secemsky EA, Belkin M, Ozaki CK, Hussain MA. Evaluating the effectiveness of systemic heparin during arteriovenous fistula creation by emulating a target trial. Am J Epidemiol. 2025 Mar 4;194(3):651-658. doi: 10.1093/aje/kwae098.

Reference Type: DERIVED

PMID: 38825327 (View on PubMed)

Heindel P, Fitzgibbon JJ, Feliz JD, Hentschel DM, Burke SK, Al-Omran M, Bhatt DL, Belkin M, Ozaki CK, Hussain MA. Evaluating national guideline concordance of recurrent interventions after radiocephalic arteriovenous fistula creation. J Vasc Surg. 2023 Apr;77(4):1206-1215.e2. doi: 10.1016/j.jvs.2022.12.017. Epub 2022 Dec 22.

Reference Type: DERIVED

PMID: 36567000 (View on PubMed)

Peden EK, Lucas JF 3rd, Browne BJ, Settle SM, Scavo VA, Bleyer AJ, Ozaki CK, Teruya TH, Wilson SE, Mishler RE, Ferris BL, Hendon KS, Moist L, Dixon BS, Wong MD, Magill M, Lindow F, Gustafson P, Burke SK; PATENCY-2 Investigators. PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency. J Vasc Access. 2022 Mar;23(2):265-274. doi: 10.1177/1129729820985626. Epub 2021 Jan 22.

Reference Type: DERIVED

PMID: 33482699 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRT-201-320

Identifier Type: -

Identifier Source: org_study_id