Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

696

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
Legemiddel: Vonapanitase
Andre navn:
  • PRT-201
Placebo komparator: Placebo
Placebo administered at the time of radiocephalic fistula creation
Legemiddel: Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Proteon Therapeutics

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2015

Primær fullføring (Faktiske)

1. februar 2018

Studiet fullført (Faktiske)

1. mai 2019

Datoer for studieregistrering

Først innsendt

8. april 2015

Først innsendt som oppfylte QC-kriteriene

10. april 2015

Først lagt ut (Anslag)

13. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PRT-201-320

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Kronisk nyre sykdom

Kliniske studier på Placebo

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Uganda

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere