Study of Haemodialysis Patients Switching From Aranesp to Biosimilar (SHADE)
5. februar 2016 opdateret af: Amgen
Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar
The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Biosimilars were approved in 2007 by the EMA in EU and in 2010 by the TGA in Australia.
This study will look at the retrospective data of patients that have switched from Darbepoetin Alfa to an approved epoetin alfa biosimilar.
Data will be collected for the 26 week period prior to switch and a 26 week period post switch to a biosimilar.
Data to be collected includes haemoglobin measurements, dose requirements, iron use, any transfusions, hospitalisations and other lab values including TSAT, Ferritin and albumin.
Data from the study will be published.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
272
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Queensland
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Herston, Queensland, Australien, 4029
- Research Site
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Nambour, Queensland, Australien, 4560
- Research Site
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Woolloongabba, Queensland, Australien, 4102
- Research Site
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Burgas, Bulgarien, 8000
- Research Site
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Egaleo, Grækenland, 12242
- Research Site
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Egaleo, Athens, Grækenland, 12244
- Research Site
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Kallithea, Athens, Grækenland, 17676
- Research Site
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Larissa, Grækenland, 41335
- Research Site
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Patra, Grækenland, 26500
- Research Site
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Patra, Grækenland, 26225
- Research Site
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Milazzo ME, Italien, 98057
- Research Site
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Pisa, Italien, 56124
- Research Site
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Chojnice, Polen, 89-600
- Research Site
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Gdansk, Polen, 80-952
- Research Site
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Krakow, Polen, 31-501
- Research Site
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Lublin, Polen, 20-954
- Research Site
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Poznan, Polen, 60-355
- Research Site
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Rybnik, Polen, 44-200
- Research Site
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Andalucía
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Jaen, Andalucía, Spanien, 23007
- Research Site
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Castilla León
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Zamora, Castilla León, Spanien, 49022
- Research Site
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Lemgo, Tyskland, 32657
- Research Site
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Lich, Tyskland, 35423
- Research Site
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Minden, Tyskland, 32429
- Research Site
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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, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The study population comprises prevalent haemodialysis (HD) patients treated at EU and Australian dialysis clinics after September 2008.
Eligible patients will have received treatment with darbepoetin alfa for at least 26 weeks prior to being converted to an EMA/TGA-approved epoetin alfa biosimilar.
At each participating study site, all potentially eligible patients are to be considered for enrolment.
Beskrivelse
Inclusion Criteria
- Patients ≥18 years of age
Patients with CKD on haemodialysis and fulfilling the following:
- Received HD for at least 26 weeks prior to switching from treatment with darbepoetin alfa to treatment with an EMA/TGA-approved epoetin alfa biosimilar
- Received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior to switching to an EMA/TGA-approved epoetin alfa biosimilar (breaks due to treatment being intentionally withheld are permitted)
- Switched from darbepoetin alfa treatment to an EMA/TGA-approved epoetin alfa biosimilar at least 26 weeks prior to enrolment
- Received at least one dose of an EMA/TGA-approved epoetin alfa biosimilar after switching from darbepoetin alfa treatment
- Mean monthly Hb 10-12g/dL in the 12 weeks prior to switch
- Stable darbepoetin alfa dose (i.e. no more than one increment or decrement of PFS) in the 12 weeks prior to switch
- Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements
Exclusion Criteria:
- Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch to biosimilar
- More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior to switch to biosimilar
- Subject received chemotherapy or major surgery during the 26 weeks prior to switch to biosimilar
- Subject was enrolled in an interventional device or drug study at any time during the 52-week data observation period or within 30 days prior to commencement of the data observation period.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Kohorte 1
Patienter med CKD
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Haemoglobin Concentration
Tidsramme: Duration of observation period -52 weeks
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Mean haemoglobin concentration over time
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Duration of observation period -52 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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ESA Doses
Tidsramme: Duration of observation period -52 weeks
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Doses of ESA over time.
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Duration of observation period -52 weeks
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Dose ratio
Tidsramme: Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)
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Dose ratio between the start of the post-switch observation period and pre-switch
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Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)
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Dose ratio
Tidsramme: Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)
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Dose ratio between the end of the post-switch observation period and pre-switch
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Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)
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Haemoglobin excursions
Tidsramme: Duration of observation period -52 weeks
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Haemoglobin excursions (<10/dL and >12g/dL)
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Duration of observation period -52 weeks
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Haemglobin within range
Tidsramme: Duration of observation period -52 weeks
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Haemoglobin in the range 10-12g/dL over time
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Duration of observation period -52 weeks
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TSAT, ferritin and albumin values
Tidsramme: Duration of observation period -52 weeks
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TSAT, ferritin and albumin over time
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Duration of observation period -52 weeks
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Iron Use
Tidsramme: Duration of observation period -52 weeks
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Iron use (dose/route) over time
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Duration of observation period -52 weeks
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Red cell transfusions (including number of units transfused)
Tidsramme: Duration of observation period -52 weeks
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Red cell transfusions (including number of units transfused)
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Duration of observation period -52 weeks
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Hospitalisations (including primary cause)
Tidsramme: Duration of observation period -52 weeks
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Hospitalisations (including primary cause)
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Duration of observation period -52 weeks
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Subjects with PRCA testing and incidence of neutralizing anti-erythropoietin antibodies
Tidsramme: Duration of 52-week observation period
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Pure Red Cell Aplasia (PRCA) test and results
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Duration of 52-week observation period
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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.
Hjælpsomme links
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
1. juni 2014
Primær færdiggørelse (Faktiske)
1. april 2015
Studieafslutning (Faktiske)
1. maj 2015
Datoer for studieregistrering
Først indsendt
7. juli 2014
Først indsendt, der opfyldte QC-kriterier
14. juli 2014
Først opslået (Skøn)
16. juli 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. februar 2016
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20130300
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 .