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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02414841
Other study ID # PRT-201-320
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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