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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02414841
Recruitment Status : Completed
First Posted : April 13, 2015
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Proteon Therapeutics

Tracking Information
First Submitted Date  ICMJE April 8, 2015
First Posted Date  ICMJE April 13, 2015
Results First Submitted Date  ICMJE May 24, 2019
Results First Posted Date  ICMJE August 13, 2019
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2019)
  • Kaplan-Meier Estimate of Secondary AVF Patency [ Time Frame: Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year. ]
    Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
  • Number of Participants With AVF Use for Hemodialysis [ Time Frame: Assessed at up to 12 Months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2015)
AVF primary unassisted patency [ Time Frame: 12 months after AVF creation ]
Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or a procedure to restore or maintain patency.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2015)
Secondary AVF patency [ Time Frame: 12 month after AVF creation ]
Secondary patency is defined as the time from AVF creation until AVF abandonment .
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: April 10, 2015)
  • Unassisted AVF maturation by ultrasound [ Time Frame: 12 months after AVF creation ]
    AVF maturation is defined by two definitions:
    1. As average cephalic vein luminal diameter ≥ 6 mm and outflow vein volume blood flow ≥ 600 mL/min by ultrasound.
    2. As average cephalic vein luminal diameter ≥ 4 mm and outflow vein volume blood flow ≥ 500 mL/min by ultrasound.
  • Unassisted AVF use for hemodialysis [ Time Frame: 12 months after AVF creation ]
    Use of the AVF for hemodialysis is defined as the ability of the study AVF to be used for hemodialysis for a minimum of 3 months.
  • Rate of procedures to restore and maintain AVF patency [ Time Frame: 12 months after AVF creation ]
    The procedure rate is defined as the total number of procedure days to restore or maintain patency divided by time on the study.
 
Descriptive Information
Brief Title  ICMJE A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
Official Title  ICMJE Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Vonapanitase
    Other Name: PRT-201
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Vonapanitase
    Vonapanitase administered at the time of radiocephalic fistula creation
    Intervention: Drug: Vonapanitase
  • Placebo Comparator: Placebo
    Placebo administered at the time of radiocephalic fistula creation
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2019)
696
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2015)
300
Actual Study Completion Date  ICMJE May 1, 2019
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02414841
Other Study ID Numbers  ICMJE PRT-201-320
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Proteon Therapeutics
Study Sponsor  ICMJE Proteon Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Proteon Therapeutics
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP