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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)

20. juli 2019 opdateret af: Proteon Therapeutics

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

696

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B7
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Science Center
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre- Royal Victoria Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85012
        • AKDHC Medical Research Services, LLC
      • Tucson, Arizona, Forenede Stater, 85724
        • Banner University Medical Center Tucson
      • Tucson, Arizona, Forenede Stater, 85745
        • AKDHC Medical Research Services, LLC
    • California
      • Loma Linda, California, Forenede Stater, 92357
        • VA Loma Linda Healthcare System
      • Long Beach, California, Forenede Stater, 90822
        • VA Medical Center Long Beach
      • Los Angeles, California, Forenede Stater, 90033
        • Keck University Hospital at USC
      • San Diego, California, Forenede Stater, 92123
        • California Institute of Renal Research
      • San Diego, California, Forenede Stater, 92120
        • Kaiser Permanente
      • San Francisco, California, Forenede Stater, 94118
        • Kaiser Permanente Northern California
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
      • Peoria, Illinois, Forenede Stater, 61603
        • RenalCare Associates, S.C.
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46804
        • Lutheran Hospital Network of Indiana
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • The University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University
    • Maine
      • Portland, Maine, Forenede Stater, 04102
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
      • Worcester, Massachusetts, Forenede Stater, 01655
        • University of Massachusetts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48105
        • VA Ann Arbor Healthcare System
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
    • Mississippi
      • Greenwood, Mississippi, Forenede Stater, 38930
        • Greenwood Leflore Hospital
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital
    • New York
      • New York, New York, Forenede Stater, 10065
        • New York Presbyterian Hospital-Weill Cornell Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina at Chapel Hill
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Health Network
      • Pittsburgh, Pennsylvania, Forenede Stater, 15240
        • VA Pittsburg Healthcare System
    • South Carolina
      • Orangeburg, South Carolina, Forenede Stater, 29118
        • SC Nephrology and Hypertension Center, Inc.
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37923
        • Knoxville Kidney Center
    • Texas
      • Austin, Texas, Forenede Stater, 78756
        • Cardiothoracis and Vascular Surgeons
      • Houston, Texas, Forenede Stater, 77030
        • The Methodist Hospital
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
    • Washington
      • Bellevue, Washington, Forenede Stater, 98004
        • Lake Washington Vascular Center
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin School of Medicine and PH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
Medicin: Vonapanitase
Andre navne:
  • PRT-201
Placebo komparator: Placebo
Placebo administered at the time of radiocephalic fistula creation
Medicin: Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Kaplan-Meier Estimate of Secondary AVF Patency
Tidsramme: 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)
Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Number of Participants With AVF Use for Hemodialysis
Tidsramme: 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.
Assessed at up to 12 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Proteon Therapeutics

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2015

Primær færdiggørelse (Faktiske)

1. februar 2018

Studieafslutning (Faktiske)

1. maj 2019

Datoer for studieregistrering

Først indsendt

8. april 2015

Først indsendt, der opfyldte QC-kriterier

10. april 2015

Først opslået (Skøn)

13. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PRT-201-320

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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