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Completed

NCT Number: NCT02110901

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

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.

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Key information

Conditions

Chronic Kidney Disease Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of at least 18 years.
  • Life expectancy of at least 6 months.
  • Diagnosis of Chronic Kidney Disease (CKD).
  • Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an existing AVF is not eligible.
  • Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
  • Written informed consent using a document that has been approved by the Institutional Review Board (IRB).
  • 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

  • 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.
  • Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
  • Previous treatment with PRT 201.
  • Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.

Treatment and study plan

PRT-201

Drug

Other names: vonapanitase

Placebo

Drug

Primary outcomes

  1. Time to AVF Primary Unassisted Patency

    Time frame: 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 unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.

  2. Kaplan-Meier Estimate of Secondary AVF Patency

    Time frame: Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year

    Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency)

Other outcomes

  1. Number of Participants With Unassisted AVF Maturation by Ultrasound

    Time frame: Assessed 3 months after AVF creation

    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.

  2. Number of Participants With Unassisted AVF Use for Hemodialysis

    Time frame: Assessed at 12 months

    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.

Sponsors and collaborators

Lead sponsor

Proteon Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Apr 10, 2014
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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