Sammenlign effektivitet/sikkerhed ved gentagne doser af ferumoxytol med jernsaccharose hos patienter med kronisk nyreinsufficiens med IDA og i hæmodialyse
31. marts 2022 opdateret af: AMAG Pharmaceuticals, Inc.
Ferumoxytol mod anæmi af CKD-forsøg (FAKTA): Et fase IV, åbent, multicenterforsøg, med MR-underundersøgelse, af gentagne doser af ferumoxytol sammenlignet med jernsaccharose til behandling af IDA hos CKD-patienter i hæmodialyse
Formålet med denne undersøgelse er at sammenligne effektiviteten og sikkerheden af gentagne doser af intravenøs (IV) ferumoxytol med IV jernsaccharose til behandling af IDA hos personer med hæmodialyse-afhængig CKD.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Dette var et fase IV, randomiseret, åbent, aktivt kontrolleret, multicenter klinisk forsøg designet til at evaluere sikkerheden, effektiviteten og hyppigheden af brugen af ferumoxytol sammenlignet med jernsaccharose til den episodiske behandling af IDA hos hæmodialysepatienter med CKD over en 1-årig periode.
Som en del af denne hovedundersøgelse blev der udført en oxidativ stress-delundersøgelse og en MR-delundersøgelse.
Oxidativ stress-underundersøgelsen, der skulle køres sideløbende med den indledende TP af hovedundersøgelsen, var at undersøge de forskellige grader, hvormed jernsaccharose og ferumoxytol kan eller ikke kan inducere oxidativt stress in vitro hos forsøgspersoner, der gennemgår hæmodialyse.
MR-underundersøgelsen, der skulle køres sideløbende med hovedundersøgelsen og fortsætte i yderligere 11 måneder, skulle vurdere potentialet for aflejring af jern i hjerte-, lever- og pancreasvæv og ændringer i laboratorieparametre over en 2-årig periode.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
296
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Montréal, Canada
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Montréal, Canada
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Toronto, Canada
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London, Det Forenede Kongerige
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London, Det Forenede Kongerige
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Arkansas
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Pine Bluff, Arkansas, Forenede Stater, 71603
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California
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Azusa, California, Forenede Stater, 91702
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Beverly Hills, California, Forenede Stater, 90211
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Los Angeles, California, Forenede Stater, 90022
- For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Los Angeles, California, Forenede Stater, 90095
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Lynwood, California, Forenede Stater, 90262
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Northridge, California, Forenede Stater, 91324
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Paramount, California, Forenede Stater, 90723
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Sacramento, California, Forenede Stater, 95815
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San Diego, California, Forenede Stater, 92123
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San Gabriel, California, Forenede Stater, 91776
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Simi Valley, California, Forenede Stater, 93065
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Whittier, California, Forenede Stater, 90603
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Whittier, California, Forenede Stater, 90603
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Connecticut
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Middlebury, Connecticut, Forenede Stater, 06762
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Florida
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Coral Springs, Florida, Forenede Stater, 33071
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Miami, Florida, Forenede Stater, 33186
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Georgia
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Augusta, Georgia, Forenede Stater, 30904
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Macon, Georgia, Forenede Stater, 31217
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40292
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
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Shreveport, Louisiana, Forenede Stater, 71103
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Massachusetts
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Framingham, Massachusetts, Forenede Stater, 01702
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Michigan
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Pontiac, Michigan, Forenede Stater, 48341
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Roseville, Michigan, Forenede Stater, 48066
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Missouri
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Farmington, Missouri, Forenede Stater, 63640
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New York
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Bronx, New York, Forenede Stater, 10641
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Brooklyn, New York, Forenede Stater, 11212
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Ridgewood, New York, Forenede Stater, 11385
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28805
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18017
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Philadelphia, Pennsylvania, Forenede Stater, 19144
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29209
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Texas
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Arlington, Texas, Forenede Stater, 76015
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Edinburg, Texas, Forenede Stater, 78539
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Houston, Texas, Forenede Stater, 78238
- For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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San Antonio, Texas, Forenede Stater, 78205
- For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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San Antonio, Texas, Forenede Stater, 78229
- For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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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 og ældre (VOKSEN, OLDER_ADULT)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Nøgleinklusionskriterier omfatter:
- Hanner og kvinder ≥18 år
- Diagnose af CKD
- Personer i dialyse skal have været i dialyse i mindst 3 måneder før screening
- Kvindelige forsøgspersoner i den fødedygtige alder, som er seksuelt aktive, skal have en effektiv præventionsmetode i mindst 1 måned før screening og acceptere at forblive på prævention indtil afslutningen af deltagelse i undersøgelsen
Nøgleekskluderingskriterier omfatter:
- Anamnese med allergi over for enten oralt eller IV jern
- Kvindelige forsøgspersoner, der er gravide eller har til hensigt at blive gravide, ammer inden for 3 måneder efter fødslen eller har en positiv serum- eller uringraviditetstest
- Parenteral jernbehandling inden for 30 dage før screening eller røde blodlegemer (RBC)/fuldblodstransfusion inden for 14 dage før screening eller planlagt under undersøgelsen
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: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: INGEN
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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EKSPERIMENTEL: Ferumoxytol
Intravenøst (IV) jern
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IV Ferumoxytol
Andre navne:
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ACTIVE_COMPARATOR: IV jernsaccharose
Intravenøst (IV) jern
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IV jernsaccharose
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hæmoglobin ændringer
Tidsramme: Op til 6 behandlingsperioder (5 uger pr. behandlingsperiode)
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Ændringer i det gennemsnitlige hæmoglobin mellem baseline og uge 5 for ferumoxytol og jernsaccharose i hver behandlingsperiode.
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Op til 6 behandlingsperioder (5 uger pr. behandlingsperiode)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændringer i transferrinmætning (TSAT)
Tidsramme: Op til 6 behandlingsperioder (5 uger pr. behandlingsperiode)
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Gennemsnitlig ændring i TSAT fra TP-baseline til uge 5 for hver TP
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Op til 6 behandlingsperioder (5 uger pr. behandlingsperiode)
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Andel af forsøgspersoner med en stigning i hæmoglobin på ≥1,0 g/dL til enhver tid fra TP-baseline til uge 5 for hver TP
Tidsramme: Op til 6 behandlingsperioder (5 uger pr. behandlingsperiode)
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Andelen af forsøgspersoner pr. gruppe, der opnår en stigning på ≥1,0 g/dL i hæmoglobin på et hvilket som helst tidspunkt i hver 5-ugers behandlingsperiode.
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Op til 6 behandlingsperioder (5 uger pr. behandlingsperiode)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
- Macdougall IC, Strauss WE, Dahl NV, Bernard K, Li Z. Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial . Clin Nephrol. 2019 Apr;91(4):237-245. doi: 10.5414/CN109512.
- Macdougall IC, Dahl NV, Bernard K, Li Z, Batycky A, Strauss WE. The Ferumoxytol for Anemia of CKD Trial (FACT)-a randomized controlled trial of repeated doses of ferumoxytol or iron sucrose in patients on hemodialysis: background and rationale. BMC Nephrol. 2017 Apr 3;18(1):117. doi: 10.1186/s12882-017-0523-8. Erratum In: BMC Nephrol. 2018 Apr 26;19(1):97.
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 2013
Primær færdiggørelse (FAKTISKE)
1. februar 2016
Studieafslutning (FAKTISKE)
1. februar 2017
Datoer for studieregistrering
Først indsendt
22. oktober 2010
Først indsendt, der opfyldte QC-kriterier
22. oktober 2010
Først opslået (SKØN)
25. oktober 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (FAKTISKE)
21. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AMAG-FER-CKD-401
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 .
Kliniske forsøg med Ferumoxytol
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Michael IvNational Cancer Institute (NCI)Trukket tilbageNeoplasma i barndommens hjerneForenede Stater
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Massachusetts General HospitalAfsluttetPapillært karcinom i skjoldbruskkirtlen | Metastatisk medullær skjoldbruskkirtelkræft | Follikulær skjoldbruskkirtelkræft lymfeknudemetastaseForenede Stater
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Allegheny Singer Research Institute (also known...Aktiv, ikke rekrutterendeNeoplasmer i leveren | Hepatocellulært karcinom | Levermetastaser | Leverkræft | Leverkarcinom | Hepatocellulær kræft | Levercirrose | Hepatisk karcinom | LeveratrofiForenede Stater
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OHSU Knight Cancer InstituteOregon Health and Science University; Radiological Society of North AmericaAfsluttetStadie III endetarmskræft AJCC v7 | Stadie IIIA endetarmskræft AJCC v7 | Stadie IIIB endetarmskræft AJCC v7 | Stadie IIIC endetarmskræft AJCC v7 | Lokalt avanceret rektalt karcinomForenede Stater
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Min ZhouRekruttering
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Michael IvAfsluttetHjerneskade | Hjernekræft | Hjernetumorer | Primær hjerneneoplasma | Iskæmisk cerebrovaskulær ulykke | Degenerativ lidelse i centralnervesystemet | Infektionslidelse i centralnervesystemet | Centralnervesystemet Vaskulær misdannelse | Hæmoragisk cerebrovaskulær ulykkeForenede Stater
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OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science University; National... og andre samarbejdspartnereAfsluttetAdenocarcinom i bugspytkirtlen | Familiær kræft i bugspytkirtlen | Pancreas intraduktal papillær-mucinøs neoplasmaForenede Stater
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Dana-Farber Cancer InstituteTrukket tilbage
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National Cancer Institute (NCI)AfsluttetProstatakræftForenede Stater
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University of EdinburghRoyal Brompton & Harefield NHS Foundation Trust; Royal Infirmary of Edinburgh og andre samarbejdspartnereAfsluttetMyokarditis | Sunde frivillige | Hjertetransplantation | Hjerte sarkoidDet Forenede Kongerige