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

NCT ID: NCT02110901

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-12-31

Brief 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.

Conditions

Chronic Kidney Disease

Study Design

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

Study Groups

PRT-201

PRT-201 administered at the time of radiocephalic fistula creation

Group Type: ACTIVE_COMPARATOR

PRT-201

Intervention Type: DRUG

Placebo

Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

PRT-201

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

vonapanitase

Eligibility Criteria

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.

• 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

AKDHC Medical Research Services, LLc

Tucson, Arizona, 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

Kaiser Permanente Medical Center

San Diego, California, United States

California Institute of Renal Research

San Diego, California, United States

UCSF Division of Vascular & Endovascular Surgery

San Francisco, California, United States

Rush Medical Center

Chicago, Illinois, United States

Renal Care Associates

Peoria, Illinois, United States

Lutheran Hospital Network of Indiana

Fort Wayne, Indiana, United States

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

Louisiana State University Health Sciences Center

Shreveport, Louisiana, United States

Maine Medical Center

Portland, Maine, United States

University of Maryland

Baltimore, Maryland, United States

University of Maryland Shore Medical Center at Easton

Easton, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

Mount Sinai Medical Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

W.G. Hefner VA Medical Center

Salisbury, North Carolina, United States

Wake Forest

Winston-Salem, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

The University of Oklahoma College of Medicine

Tulsa, Oklahoma, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

VA Pittsburg Healthcare System

Pittsburgh, Pennsylvania, United States

The Methodist Hospital

Houston, Texas, United States

Lake Washington Vascular Center

Bellevue, Washington, United States

Countries

United States

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)

Bleyer AJ, Scavo VA, Wilson SE, Browne BJ, Ferris BL, Ozaki CK, Lee T, Peden EK, Dixon BS, Mishler R, O'Connor TP, Kidd K, Burke SK; PATENCY-1 Investigators. A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis. J Vasc Surg. 2019 Feb;69(2):507-515. doi: 10.1016/j.jvs.2018.04.068.

Reference Type: DERIVED

PMID: 30683197 (View on PubMed)

Other Identifiers

PRT-201-310

Identifier Type: -

Identifier Source: org_study_id