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Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 (DIALOGUE4)

17. september 2019 opdateret af: Bayer

A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis and on Treatment With an Erythropoiesis-stimulating Agent in the United States and Japan

Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

201

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Azusa, California, Forenede Stater, 91702
      • Long Beach, California, Forenede Stater, 90813
      • Los Angeles, California, Forenede Stater, 90025
      • Lynwood, California, Forenede Stater, 90262
      • Northridge, California, Forenede Stater, 91324
      • San Dimas, California, Forenede Stater, 91773
      • Whittier, California, Forenede Stater, 90606
      • Whittier, California, Forenede Stater, 90602
    • Florida
      • New Port Richey, Florida, Forenede Stater, 34652
      • Pembroke Pines, Florida, Forenede Stater, 33028
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48236
      • Detroit, Michigan, Forenede Stater, 48202
    • Missouri
      • Creve Coeur, Missouri, Forenede Stater, 63141
    • New Jersey
      • Eatontown, New Jersey, Forenede Stater, 07724
    • New York
      • Brooklyn, New York, Forenede Stater, 11212
      • Buffalo, New York, Forenede Stater, 14215
      • Fresh Meadows, New York, Forenede Stater, 11365
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45206
      • Toledo, Ohio, Forenede Stater, 43615
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73116
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37212-8150
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
      • Fort Worth, Texas, Forenede Stater, 76105
      • Fort Worth, Texas, Forenede Stater, 76164
      • Grand Prairie, Texas, Forenede Stater, 75050
      • Houston, Texas, Forenede Stater, 77004
      • Houston, Texas, Forenede Stater, 77091
      • Mansfield, Texas, Forenede Stater, 76063
      • San Antonio, Texas, Forenede Stater, 78229
      • San Antonio, Texas, Forenede Stater, 78215
  • Japan
      • Kyoto, Japan, 607-8116
      • Nagano, Japan, 388-8004
    • Hokkaido
      • Muroran, Hokkaido, Japan, 050-0083
    • Hyogo
      • Himeji, Hyogo, Japan, 670-0947
    • Mie
      • Kuwana, Mie, Japan, 511-0061

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

Beskrivelse

Inclusion Criteria:

  • - Eligible subjects will have a diagnosis of anemia associated with CKD(chronic kidney disease).
  • Women without childbearing potential
  • Male or female subject ≥ 18 years of age with anemia of CKD at screening
  • On dialysis, defined as regular long-term hemodialysis, with the same modality of dialysis for ≥ 3 months before randomization
  • Dialysis vascular access via native arteriovenous fistula, synthetic graft, long-term catheters, or long-term tunneled catheters
  • Treated with epoetin alfa (US or Japan) or epoetin beta (Japan) via intravenous (IV) or subcutaneous (SC) route, on stable dosing defined as a < 50% change from the maximum prescribed weekly dose with no change in the prescribed frequency during the last 8 weeks prior to randomization
  • At least one kidney
  • Mean screening Hb concentration 9.0 to 11.5 g/dL inclusive (mean of all local laboratory Hb measurements [at least 2 measurements must be taken ≥ 2 days apart] during the 4 week screening period, AND none of the measurements can be < 9.0 g/dL or > 12.0 g /dL
  • Serum ferritin levels ≥ 100 μg/L OR transferrin saturation ≥ 20% at screening. Iron substitution is allowed
  • Folate and vitamin B12 levels above the lower limit of normal. Supplementation is allowed
  • Exclusion Criteria:
  • Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
  • Hereditary hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia
  • Chronic lymphoproliferative diseases
  • Any allograft (including renal allograft) in place and on immunosuppressive therapy, or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)
  • Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease)
  • Subjects treated with immuno- or myelosuppressive therapy within 8 weeks prior to randomization: e.g., everolimus, sirolimus, rituximab, azathioprine, mycophenolate mofetil, mycophenolic acid, cyclosporine,methotrexate, and tacrolimus, chemotherapeutic agents and other anticancer agents, and systemic steroids (except inhaled steroids) for 7 days
  • RBC-containing transfusion within 8 weeks before randomization
  • History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from the initial screening visit
  • Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively
  • Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT >500 msec, second or third degree atrioventricular [AV]block if not treated with a pacemaker)
  • New York Heart Association Class III or IV congestive heart failure
  • Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST], or gamma-glutamyl transferase > 3 times the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator's opinion
  • A scheduled surgery that may be expected to lead to significant blood loss

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
Eksperimentel: Molidustat (BAY 85-3934)(25mg)
Starting dose of 25 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
Medicin: Molidustat (BAY 85-3934)
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
Eksperimentel: Molidustat (BAY 85-3934)(50mg)
Starting dose of 50 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
Medicin: Molidustat (BAY 85-3934)
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
Eksperimentel: Molidustat (BAY 85-3934) (75mg)
Starting dose of 75 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.,
Medicin: Molidustat (BAY 85-3934)
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
Eksperimentel: Molidustat (BAY 85-3934) (150mg)
Starting dose of 150 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, 150 and 200 mg once daily
Medicin: Molidustat (BAY 85-3934)
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
Aktiv komparator: Epoetin alfa/beta
Starting dose at the subject's current weekly dose. Administered IV or SC 3 times per week. Doses will be titrated at the scheduled dose control visits according to the local label. Titration will be based on the subject's Hb response and tolerability of the prior dose. Epoetin alfa may be administered in either the United States (US) or Japan; epoetin beta will only be administered in Japan.
Biologisk: Epoetin alfa/beta

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Tidsramme: Baseline and weeks 14 to 17
Baseline and weeks 14 to 17

Sekundære resultatmål

Resultatmål
Tidsramme
Duration of exposure on each dose level
Tidsramme: Up to 16 weeks
Up to 16 weeks
Number of subjects requiring titration of dose
Tidsramme: Up to 16 weeks
Up to 16 weeks
Number of participants with serious adverse events as a measure of safety and tolerability
Tidsramme: Up to 16 weeks
Up to 16 weeks
Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)
Tidsramme: From week 14 to 17
From week 14 to 17
Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)
Tidsramme: From week 14 to 17
From week 14 to 17
Change from baseline in Hb during active treatment
Tidsramme: Baseline and weeks 14 to 17
Baseline and weeks 14 to 17
Number of patients with hemoglobin levels outside the target range
Tidsramme: From week 14 to 17
From week 14 to 17
Dose level in the evaluation period
Tidsramme: Up to 16 weeks
Up to 16 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayer

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

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)

28. oktober 2013

Primær færdiggørelse (Faktiske)

23. oktober 2015

Studieafslutning (Faktiske)

15. december 2015

Datoer for studieregistrering

Først indsendt

18. oktober 2013

Først indsendt, der opfyldte QC-kriterier

29. oktober 2013

Først opslået (Skøn)

5. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 16208

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 Nyreinsufficiens, kronisk

Kliniske forsøg med Molidustat (BAY 85-3934)

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