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Et forsøk som sammenligner Ferumoxytol med jernsukrose for behandling av jernmangelanemi

31. mars 2022 oppdatert av: AMAG Pharmaceuticals, Inc.

En fase III, randomisert, åpen, aktiv kontrollert, prøve som sammenligner Ferumoxytol med jernsukrose for behandling av jernmangelanemi

Formålet med studien er å evaluere effektiviteten og sikkerheten til intravenøs (IV) ferumoksytol sammenlignet med IV jernsukrose for behandling av jernmangelanemi (IDA).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

605

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Australia
      • Adelaide, Australia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ballarat, Australia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Concord, Australia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Five Dock, Australia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gosford, Australia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kingswood, Australia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Parkville, Australia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Frankrike
      • La Tronche, Frankrike
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Italia
      • Padova, Italia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rozzano, Italia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Korea, Republikken
      • Cheonan, Korea, Republikken
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Daegu, Korea, Republikken
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Incheon, Korea, Republikken, 400-711
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Incheon, Korea, Republikken, 405-760
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republikken, 110-774
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republikken, 134-701
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republikken, 135-710
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republikken, 138-736
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republikken, 158-710
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republikken
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Suwon, Korea, Republikken, 442-723
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Suwon, Korea, Republikken, 443-721
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Latvia
      • Daugavpils, Latvia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga, Latvia, LV-1002
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga, Latvia, LV-1005
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga, Latvia, LV-1006
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga, Latvia, LV-1010
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga, Latvia, LV-1013
        • For additional this triinformation regarding investigative sites for al, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ventspils, Latvia, LV-3601
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ventspils, Latvia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Litauen
      • Kaunas, Litauen, LT-48259
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kaunas, Litauen, LT-49449
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kaunas, Litauen, LT-50009
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kaunas, Litauen, LT-50185
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Klaipėda, Litauen
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vilnius, Litauen, LT-03215
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vilnius, Litauen, LT-08661
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Šiauliai, Litauen
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Polen
      • Białystok, Polen
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Katowice, Polen
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kraków, Polen
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sopot, Polen
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Warszawa, Polen, 02-341
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Warszawa, Polen, 03-580
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wrocław, Polen
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zgierz, Polen
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Łęczyca, Polen
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Romania
      • Braşov, Romania
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bucharest, Romania, 011422
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bucharest, Romania, 020125
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Iaşi, Romania
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Suceava, Romania
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Timişoara, Romania, 300158
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Timişoara, Romania, 300593
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Târgu-Mureş, Romania, 540136
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Târgu-Mureş, Romania, 540461
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Spania
      • Barcelona, Spania
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Manresa, Spania
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Santa Cruz De Tenerife, Spania
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sevilla, Spania
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Storbritannia
      • Cambridge, Storbritannia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • London, Storbritannia
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Sør-Afrika
      • Cape Town, Sør-Afrika, 7500
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cape Town, Sør-Afrika, 7530
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Durban, Sør-Afrika, 4001
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Durban, Sør-Afrika, 4091
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Roodepoort, Sør-Afrika
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Stellenbosch, Sør-Afrika
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Tyskland
      • Berlin, Tyskland
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Frankfurt, Tyskland, 60322
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Frankfurt, Tyskland, 60431
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mainz, Tyskland, 55131
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mainz, Tyskland, D-55116
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Siegen, Tyskland
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wilhelmshaven, Tyskland
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Ukraina
      • Cherkasy, Ukraina
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Chernivtsi, Ukraina
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Donetsk, Ukraina, 83045
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Donetsk, Ukraina, 83114
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ivano-Frankivsk, Ukraina
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv, Ukraina, 01030
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv, Ukraina, 01034
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv, Ukraina, 04050
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv, Ukraina, 04112
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Odessa, Ukraina
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Simferopol, Ukraina
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vinnytsya, Ukraina
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zaporizhzhya, Ukraina
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Ungarn
      • Békéscsaba, Ungarn
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gyula, Ungarn
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Komárom, Ungarn
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Miskolc, Ungarn
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Szekszárd, Ungarn
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Szolnok, Ungarn
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vác, Ungarn
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zalaegerszeg, Ungarn
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Viktige inkluderingskriterier inkluderer:

  1. Hanner og kvinner ≥18 år

  2. Deltakere med IDA definert som å ha:

    1. Hemoglobin <10,0 g/desiliter (dL)
    2. Transferrinmetning (TSAT) <20 %
  3. Deltakere som har en historie med utilfredsstillende oral jernbehandling eller som ikke kan brukes oralt jern
  4. Kvinnelige deltakere i fertil alder som er seksuelt aktive må ha en effektiv prevensjonsmetode i minst 1 måned før screening og samtykke i å forbli på prevensjon til fullført deltakelse i studien

Viktige eksklusjonskriterier inkluderer:

  1. Historie med allergi mot IV jern
  2. Allergi mot to eller flere medikamentklasser
  3. Deltakere i dialyse eller med en estimert glomerulær filtrasjonshastighet <30 ml/minutt(min)/1,73 kvadratmeter (m^2)
  4. Kvinnelige deltakere som er gravide, har til hensikt å bli gravide, ammer, innen 2 uker etter fødselen, eller har en positiv serum-/uringraviditetstest
  5. Hemoglobin ≤7,0 g/dL
  6. Serumferritin >600 nanogram/ml

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Ferumoksytol
Deltakerne fikk totalt 2 doser IV ferumoksytol 510 milligram (mg) (17 milliliter [ml]). Den første IV-dosen på 510 mg ble administrert på dag 1 (grunnlinje) og andre dose 2 til 8 (5±3) dager etter den første dosen, for en total kumulativ dose på 1,02 gram (g).
Legemiddel: Ferumoksytol
IV Ferumoxytol
Andre navn:
  • Feraheme
Aktiv komparator: Jern sukrose
Deltakerne fikk en IV-injeksjon eller infusjon av jernsukrose 200 mg (10 ml) på dag 1 (grunnlinje) og på 4 andre ikke-påfølgende dager over en 14-dagers periode, for en total kumulativ dose på 1,0 g. Deltakere som fikk sin første eksponering for IV jernsukrose, fikk en testdose på dag 1 før de fikk resten av den første dosen, som foreskrevet i pakningsvedlegget for enkelte land.
Legemiddel: Jern sukrose
IV Jern sukrose
Andre navn:
  • Venofer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Deltakere som oppnådde en ≥2,0 g/dL økning i hemoglobin når som helst fra baseline til uke 5
Tidsramme: Grunnlinje (dag 1) til og med uke 5

Deltakere som oppnådde en ≥2,0 g/dL økning i hemoglobin til enhver tid fra baseline opp til uke 5, presenteres. Økning i hemoglobin til enhver tid fra baseline opp til uke 5 ble beregnet for hver deltaker basert på:

Hemoglobinforandring = Hemoglobin (Uke X) - Hemoglobin (Baseline), der Uke X var et hvilket som helst post-Baseline-besøk til og med uke 5.

Baseline ble definert som dag 1-verdien (før injeksjon av studiemedikamentet). Screeningen eller den siste verdien før dag 1 ble brukt for alle deltakere med manglende informasjon om dag 1. Deltakere uten hemoglobinverdier etter baseline ble klassifisert som ikke å oppnå en økning på ≥2,0 g/dL.

Statistisk analyse ble kun utført for data opp til uke 5.
Grunnlinje (dag 1) til og med uke 5

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Deltakere som oppnår et hemoglobinnivå ≥12,0 g/dL når som helst fra baseline til uke 5
Tidsramme: Grunnlinje (dag 1) til og med uke 5

Deltakere som oppnådde et hemoglobinnivå på ≥12,0 g/dL til enhver tid fra baseline opp til uke 5, presenteres. Økning i hemoglobin til enhver tid fra baseline opp til uke 5 ble beregnet for hver deltaker basert på:

Hemoglobinforandring = Hemoglobin (Uke X) - Hemoglobin (Baseline), der Uke X var et hvilket som helst post-Baseline-besøk til og med uke 5. Baseline ble definert som Dag 1-verdien (før injeksjon av studiemedisin). Screeningen eller den siste verdien før dag 1 ble brukt for alle deltakere med manglende informasjon om dag 1. Deltakere uten hemoglobinverdier etter baseline ble behandlet som ikke-respondere.
Grunnlinje (dag 1) til og med uke 5
Gjennomsnittlig endring i hemoglobin fra baseline til uke 5
Tidsramme: Grunnlinje (dag 1), uke 5

Gjennomsnittlig endring i hemoglobin fra baseline til uke 5 ble beregnet for hver deltaker som: Hemoglobin Change = Hemoglobin (Uke 5) - Hemoglobin (Baseline).

Baseline ble definert som dag 1-verdien (før injeksjon av studiemedikamentet). Screeningen eller den siste verdien før dag 1 ble brukt for alle deltakere med manglende informasjon om dag 1. Hvis hemoglobinverdien for uke 5 manglet, ble endringen fra baseline beregnet til null.
Grunnlinje (dag 1), uke 5
Gjennomsnittlig endring i TSAT fra baseline til uke 5
Tidsramme: Grunnlinje (dag 1), uke 5

Gjennomsnittlig endring i TSAT fra baseline til uke 5 ble beregnet for hver deltaker som: TSAT Change = TSAT (Uke 5) - TSAT (Baseline).

Baseline ble definert som dag 1-verdien (før injeksjon av studiemedikamentet). Screeningen eller den siste verdien før dag 1 ble brukt for alle deltakere med manglende informasjon om dag 1. Hvis TSAT-verdien for uke 5 manglet, ble endringen fra baseline beregnet til null.
Grunnlinje (dag 1), uke 5
Gjennomsnittlig endring i funksjonell vurdering av kronisk sykdomsterapi (FACIT)-tretthetsscore fra baseline til uke 5
Tidsramme: Grunnlinje (dag 1), uke 5

FACIT-Fatigue-spørreskjemaet er et 13-elements spørreskjema designet og validert for å spesifikt vurdere tilstedeværelsen og effekten av behandling på tretthet og relaterte symptomer, som tretthet, på helserelatert livskvalitet hos anemiske deltakere med kreft. Spørreskjemaet har 13 elementer, hver målt på en 4-punkts Likert-skala. Poengsummen varierer fra 0 (de mest slitne) til 52 (de minst slitne) poeng, med høyere poeng som representerer bedre funksjon eller mindre utmattelse.

Gjennomsnittlig endring i FACIT-tretthetsscore fra baseline til uke 5 ble beregnet for hver deltaker som:

FACIT-tretthetspoengsum endring = FACIT-tretthetspoeng (uke 5) - FACIT-tretthetspoeng (grunnlinje).

Baseline ble definert som dag 1-verdien (før første dose av studiemedikamentet). Screeningen eller siste verdi før dag 1 ble brukt for alle deltakere med manglende informasjon om dag 1. Hvis Uke 5 FACIT-Tretthetsscore-verdien manglet, ble endringen fra Baseline beregnet til null.
Grunnlinje (dag 1), uke 5
Tid til hemoglobinøkning på ≥2,0 g/dL eller hemoglobinverdi på ≥12,0 g/dL fra baseline
Tidsramme: Fra baseline (dag 1) til uke 5
Tiden til hemoglobinøkning på ≥2,0 g/dL eller hemoglobinverdi på ≥12,0 g/dL ble definert som dagene fra baseline (dag 1) til første gang deltakeren hadde en økning i hemoglobin på ≥2,0 g/dL eller hemoglobin verdi på ≥12,0 g/dL, og ble beregnet ved å bruke en Kaplan-Meier-kurve. Deltakere som ikke hadde en hemoglobinøkning på ≥2,0 g/dL eller til et hemoglobinnivå ≥12,0 g/dL ble sensurert ved siste besøksdag. Deltakere uten studiebesøk etter baseline ble ikke inkludert.
Fra baseline (dag 1) til uke 5

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Publikasjoner og nyttige lenker

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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)

10. august 2010

Primær fullføring (Faktiske)

9. november 2011

Studiet fullført (Faktiske)

25. juni 2012

Datoer for studieregistrering

Først innsendt

29. april 2010

Først innsendt som oppfylte QC-kriteriene

30. april 2010

Først lagt ut (Anslag)

3. mai 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AMAG-FER-IDA-302

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