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Trial record 1 of 1 for:    NCT02414841
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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)

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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

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Vonapanitase Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 696 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Actual Study Start Date : August 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
Drug: Vonapanitase
Other Name: PRT-201

Placebo Comparator: Placebo
Placebo administered at the time of radiocephalic fistula creation
Drug: Placebo



Primary Outcome Measures :
  1. 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)

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414841


Locations
Show Show 41 study locations
Sponsors and Collaborators
Proteon Therapeutics
  Study Documents (Full-Text)

Documents provided by Proteon Therapeutics:

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Responsible Party: Proteon Therapeutics
ClinicalTrials.gov Identifier: NCT02414841    
Other Study ID Numbers: PRT-201-320
First Posted: April 13, 2015    Key Record Dates
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019
Last Verified: July 2019
Keywords provided by Proteon Therapeutics:
radiocephalic
arteriovenous fistula
AVF
hemodialysis
PRT-201
vonapanitase
vascular access
kidney
renal
PATENCY-2
secondary patency
fistula abandonment
use for hemodialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Arteriovenous Fistula
Fistula
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities