- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02964936
A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia
8. april 2021 opdateret af: Astellas Pharma Inc
A Phase 3, Multicenter, Randomized, 2-Arm, Open-label Study of Intermittent Oral Dosing of ASP1517 for the Treatment of Anemia in Erythropoiesis Stimulating Agent-untreated Chronic Kidney Disease Patients Not on Dialysis
The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Aichi, Japan
- Site JP00018
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Aichi, Japan
- Site JP00028
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Aichi, Japan
- Site JP00007
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Chiba, Japan
- Site JP00001
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Ehime, Japan
- Site JP00035
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Fukui, Japan
- Site JP00012
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Fukuoka, Japan
- Site JP00031
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Fukuoka, Japan
- Site JP00011
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Hiroshima, Japan
- Site JP00034
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Hiroshima, Japan
- Site JP00030
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Hiroshima, Japan
- Site JP00036
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Hokkaido, Japan
- Site JP00005
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Hyogo, Japan
- Site JP00020
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Ibaraki, Japan
- Site JP00017
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Ibaraki, Japan
- Site JP00015
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Ibaraki, Japan
- Site JP00021
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Ibaraki, Japan
- Site JP00025
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Ibaraki, Japan
- Site JP00037
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Ishikawa, Japan
- Site JP00033
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Iwate, Japan
- Site JP00029
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Kanagawa, Japan
- Site JP00014
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Kanagawa, Japan
- Site JP00006
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Kanagawa, Japan
- Site JP00038
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Miyagi, Japan
- Site JP00010
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Nagano, Japan
- Site JP00016
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Niigata, Japan
- Site JP00024
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Oita, Japan
- Site JP00032
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Osaka, Japan
- Site JP00026
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Osaka, Japan
- Site JP00009
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Osaka, Japan
- Site JP00003
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Saitama, Japan
- Site JP00027
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Saitama, Japan
- Site JP00002
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Saitama, Japan
- Site JP00019
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Tokyo, Japan
- Site JP00013
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Tokyo, Japan
- Site JP00004
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Tokyo, Japan
- Site JP00022
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Tokyo, Japan
- Site JP00023
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Toyama, Japan
- Site JP00008
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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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subjects who were diagnosed with non-dialysis chronic kidney disease (CKD) and who are considered not to require renal replacement therapy during the study period
- Mean of the subject's two most recent Hb values before randomization during the Screening Period must be <10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values
- Either transferrin saturation ≥ 5% or serum ferritin ≥ 30 ng/mL
- Female subject must either:
Be of non-childbearing potential:
- post-menopausal prior to pre-screening, or
- documented surgically sterile Or, if of childbearing potential,
- Agree not to try to become pregnant during the study after informed consent acquisition and for 28 days after the final study drug administration
- And have a negative urine pregnancy test at pre-screening
- And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at pre-screening and throughout the study period and for 28 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at pre-screening and throughout the study period, and for 28 days after the final study drug administration.
- Female subject must not donate ova starting at pre-screening and throughout the study period, and for 28 days after the final study drug administration.
- Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective birth control (at least one of which must be a barrier method) starting at pre-screening and continue throughout the study period, and for 12 weeks after the final study drug administration
- Male subject must not donate sperm starting at pre-screening and throughout the study period, and for 12 weeks after the final study drug administration
Exclusion Criteria:
- Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment
- Concurrent autoimmune disease with inflammation that could impact erythropoiesis
- History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastroparesis
- Uncontrolled hypertension
- Concurrent congestive heart failure (NYHA Class III or higher)
- History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the pre-screening assessment
- Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the pre-screening assessment, or positive for human immunodeficiency virus (HIV) in a past test
- Concurrent other form of anemia than renal anemia
- Having received treatment with ESA, protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the pre-screening assessment
- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) or total bilirubin that is greater than the criteria, or previous or concurrent another serious liver disease at pre-screening assessment
- Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
- Having undergone red blood transfusion and/or a surgical procedure considered to promote anemia within 4 weeks before the pre-screening assessment
- Having undergone a kidney transplantation
- History of serious drug allergy including anaphylactic shock
- Having a previous history of treatment with ASP1517
- Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: ASP1517 Low dose group
Study drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
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Oral administration
Andre navne:
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Eksperimentel: ASP1517 High dose group
Study drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
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Oral administration
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from baseline in hemoglobin (Hb) response rate
Tidsramme: Baseline and week 24
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Hb response is defined as reaching target values for Hb.
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Baseline and week 24
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Tid til at nå den nedre grænse for mål-Hb-niveauet
Tidsramme: Op til uge 24
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Op til uge 24
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Livskvalitet vurderet af FACT-An
Tidsramme: Op til uge 24
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FAKTA-AN: Funktionel vurdering af kræftterapi-anæmi
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Op til uge 24
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Sikkerhed vurderet ved forekomst af uønskede hændelser
Tidsramme: Op til uge 24
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Op til uge 24
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Antal deltagere med unormale vitale tegn og/eller bivirkninger relateret til behandlingen
Tidsramme: Op til uge 24
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Op til uge 24
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Sikkerhed vurderet ved standard 12-aflednings elektrokardiogram
Tidsramme: Op til uge 24
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Op til uge 24
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Antal deltagere med unormale laboratorieværdier og/eller bivirkninger relateret til behandlingen
Tidsramme: Op til uge 24
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Op til uge 24
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Plasmakoncentration af uændret ASP1517
Tidsramme: Op til uge 24
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Op til uge 24
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Gennemsnitligt hæmatokritniveau
Tidsramme: Op til uge 24
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Op til uge 24
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Gennemsnitligt retikulocytniveau
Tidsramme: Op til uge 24
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Op til uge 24
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Gennemsnitligt jernniveau (Fe).
Tidsramme: Op til uge 24
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Op til uge 24
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Gennemsnitligt ferritinniveau
Tidsramme: Op til uge 24
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Op til uge 24
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Gennemsnitligt transferrinniveau
Tidsramme: Op til uge 24
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Op til uge 24
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Gennemsnitligt niveau for total jernbindingskapacitet
Tidsramme: Op til uge 24
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Op til uge 24
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Gennemsnitligt niveau af opløselig transferrinreceptor
Tidsramme: Op til uge 24
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Op til uge 24
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Gennemsnitligt transferrinmætningsniveau
Tidsramme: Op til uge 24
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Op til uge 24
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Gennemsnitligt retikulocythæmoglobinindhold
Tidsramme: Op til uge 24
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Op til uge 24
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Antal indlæggelser
Tidsramme: Op til uge 24
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Op til uge 24
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Varighed af indlæggelser
Tidsramme: Op til uge 24
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Op til uge 24
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Ændring fra baseline i den gennemsnitlige Hb fra uge 18 til uge 24
Tidsramme: Baseline og uge 18 til 24
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Baseline og uge 18 til 24
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Proportion of participants who achieve the target Hb level at the average of Week 18 to 24
Tidsramme: Weeks 18 to 24
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Hb response defined as average Hb within the target range in this outcome
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Weeks 18 to 24
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Rate of rise in Hb levels (g/dL/week) from week 0 at the earliest date of week 4, time to discontinuation, or time of dose adjustment
Tidsramme: Up to Week 4
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Up to Week 4
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Proportion of measurement points with the target Hb level
Tidsramme: Weeks 18 to 24
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Weeks 18 to 24
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Proportion of participants who achieves the target Hb level at each week
Tidsramme: Up to Week 24
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Up to Week 24
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Proportion of participants who achieves the lower limit of the target Hb level
Tidsramme: Up to Week 24
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Up to Week 24
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Change from baseline in Hb level to each week
Tidsramme: Baseline and Up to Week 24
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Baseline and Up to Week 24
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Quality of life assessed by EQ-5D-5L
Tidsramme: Up to Week 24
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EQ-5D: EuroQol 5 Dimension 5 Levels
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Up to Week 24
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Safety assessed by body weight
Tidsramme: Up to Week 24
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Up to Week 24
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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 (Faktiske)
11. januar 2017
Primær færdiggørelse (Faktiske)
15. august 2018
Studieafslutning (Faktiske)
15. august 2018
Datoer for studieregistrering
Først indsendt
13. november 2016
Først indsendt, der opfyldte QC-kriterier
13. november 2016
Først opslået (Skøn)
16. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1517-CL-0314
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development.
Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared.
Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD-delingstidsramme
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD-delingsadgangskriterier
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
The research proposal is reviewed by an Independent Research Panel.
If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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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