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Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934 (DIALOGUE 2)

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 (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in Europe and Asia Pacific

Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.

The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 15 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this research.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

126

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Gosford, New South Wales, Australien, 2250
    • Victoria
      • Reservoir, Victoria, Australien, 3073
  • Bulgarien
      • Dobrich, Bulgarien, 9300
      • Lovech, Bulgarien, 5500
      • Montana, Bulgarien, 3400
      • Pazardjik, Bulgarien, 4400
      • Sofia, Bulgarien, 1872
      • Stara Zagora, Bulgarien, 6000
  • Det Forenede Kongerige
      • Liverpool, Det Forenede Kongerige, L7 8XP
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
  • Frankrig
      • Grenoble Cedex 9, Frankrig, 38043
      • Pierre Benite Cedex, Frankrig, 69495
  • Israel
      • Ashkelon, Israel, 7827804
      • Hadera, Israel, 3810101
      • Kfar Saba, Israel, 4428164
      • Nahariya, Israel, 2210001
  • Italien
    • Campania
      • Napoli, Campania, Italien, 80138
    • Lombardia
      • Brescia, Lombardia, Italien, 25123
      • Cremona, Lombardia, Italien, 26100
      • Lecco, Lombardia, Italien, 23900
      • Pavia, Lombardia, Italien, 27100
    • Toscana
      • Livorno, Toscana, Italien, 57023
  • Japan
      • Chiba, Japan, 260-8712
      • Fukuoka, Japan, 810-8563
      • Nagano, Japan, 388-8004
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 802-8555
      • Okawa, Fukuoka, Japan, 831-0016
    • Hokkaido
      • Muroran, Hokkaido, Japan, 050-0083
    • Iwate
      • Morioka, Iwate, Japan, 020-0066
    • Kanagawa
      • Fujisawa, Kanagawa, Japan, 251-8550
    • Mie
      • Kuwana, Mie, Japan, 511-0061
  • Kalkun
      • Ankara, Kalkun, 06100
        • Ankara Univ. Medical Faculty
      • Ankara, Kalkun, 06490
        • Baskent University Medical faculty
      • Izmir, Kalkun, 03540
        • Sifa University Medical Faculty
  • Korea, Republikken
    • Gyeonggido
      • Bucheon-si, Gyeonggido, Korea, Republikken, 420-767
  • Polen
      • Bialystok, Polen, 15-540
      • Radom, Polen, 26-610
  • Rumænien
      • Bucharest, Rumænien, 010731
      • Bucharest, Rumænien, 020475
      • Oradea, Rumænien, 410469
      • Targu-Mures, Rumænien, 540103
  • Spanien
      • Madrid, Spanien, 28007
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
    • Madrid
      • San Sebastián de los Reyes, Madrid, Spanien, 28702
  • Tyskland
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Tyskland, 53127
  • Ungarn
      • Baja, Ungarn, 6500
      • Budapest, Ungarn, 1036
      • Esztergom, Ungarn, 2500
      • Kaposvar, Ungarn, 7400
      • Pecs, Ungarn, 7624
      • Szigetvar, Ungarn, 7900

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:

  • Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
  • Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease or the formula according to Matsuo, et al.)
  • Not on dialysis and not expected to begin dialysis during the treatment period of the study (at least 16 weeks from randomization)
  • Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8 weeks prior to randomization
  • At least one kidney
  • Mean screening hemoglobin (Hb) concentration of 10.0 to 12.0 g/dL
  • Men who agree to use adequate contraception when sexually active or women without childbearing potential

Exclusion Criteria:

  • Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
  • Active hemolysis or diagnosis of hemolytic syndrome
  • History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure red-cell aplasia (PRCA)
  • History of hemosiderosis or hemochromatosis
  • Hereditary hemoglobinopathies (such as sickle cell disease and thalassemia major)
  • Aplastic anemia
  • Chronic lymphoproliferative diseases
  • Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy that is likely to require invasive treatment (intraocular injections or laser photocoagulation) during the study
  • Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
  • Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
  • Uncontrolled and symptomatic hyperparathyroidism
  • Uncontrolled active infection
  • Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated > 3 years prior to randomization
  • 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)

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: BAY85-3934 (25mg)
Fixed starting dose of 25 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.
Medicin: BAY85-3934
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
Eksperimentel: BAY85-3934 (50mg)
Fixed starting dose of 50 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled 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, and 150 mg once daily.
Medicin: BAY85-3934
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
Eksperimentel: BAY85-3934 (75mg)
Fixed starting doses of 75 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled 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, and 150 mg once daily.
Medicin: BAY85-3934
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
Aktiv komparator: Darbepoetin alfa
Darbepoetin (intravenous or subcutaneous) will be administered according to the local label and titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose.
Biologisk: Darbepoetin alfa

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 week 12 to 16
Baseline and week 12 to 16

Sekundære resultatmål

Resultatmål
Tidsramme
Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Tidsramme: Up to 16 weeks
Up to 16 weeks
Change in hemoglobin level
Tidsramme: Baseline up to 16 weeks
Baseline up to 16 weeks
Number of patients with hemoglobin levels outside the target range
Tidsramme: Week 12 to 16
Week 12 to 16
Dose level in the evaluation period
Tidsramme: Week 12 to 16
Week 12 to 16
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

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. januar 2014

Primær færdiggørelse (Faktiske)

15. oktober 2015

Studieafslutning (Faktiske)

23. november 2015

Datoer for studieregistrering

Først indsendt

20. december 2013

Først indsendt, der opfyldte QC-kriterier

20. december 2013

Først opslået (Skøn)

27. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. 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

  • 15261
  • 2013-001192-21 (EudraCT nummer)

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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Kliniske forsøg med BAY85-3934

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner