15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific) (DIALOGUE 1)
17. september 2019 opdateret af: Bayer
A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease Not Currently Treated With Erythropoiesis-stimulating Agent 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 14 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 5 hospitals in the UK. Bayer HealthCare AG is funding this research.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
121
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Gosford, New South Wales, Australien, 2250
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Victoria
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Melbourne, Victoria, Australien, 3052
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Gabrovo, Bulgarien, 5300
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Lovech, Bulgarien, 5500
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Montana, Bulgarien, 3400
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Pazardjik, Bulgarien, 4400
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Stara Zagora, Bulgarien, 6000
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Veliko Tarnovo, Bulgarien, 5000
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London, Det Forenede Kongerige, SE5 9RS
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Cambridgeshire
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Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
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South Yorkshire
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Doncaster, South Yorkshire, Det Forenede Kongerige, DN2 5LT
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Limoges Cedex1, Frankrig, 87042
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Ashkelon, Israel, 7827804
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Hadera, Israel, 3810101
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Nahariya, Israel, 2210001
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Campania
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Napoli, Campania, Italien, 80138
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Emilia-Romagna
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Modena, Emilia-Romagna, Italien, 41100
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Lombardia
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Cremona, Lombardia, Italien, 26100
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Pavia, Lombardia, Italien, 27100
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Toscana
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Livorno, Toscana, Italien, 57023
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Chiba, Japan, 260-8712
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Fukuoka, Japan, 810-8563
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Nara, Japan, 630-8581
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Fukuoka
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Kitakyushu, Fukuoka, Japan, 802-8555
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Okawa, Fukuoka, Japan, 831-0016
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Hokkaido
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Muroran, Hokkaido, Japan, 050-0083
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Ishikawa
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Hakusan, Ishikawa, Japan, 924-8588
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Iwate
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Morioka, Iwate, Japan, 020-0066
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Kanagawa
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Kamakura, Kanagawa, Japan, 247-8533
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Mie
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Kuwana, Mie, Japan, 511-0061
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Ankara, Kalkun, 06100
- Ankara Univ. Medical Faculty
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Ankara, Kalkun, 06490
- Baskent University Medical faculty
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Izmir, Kalkun, 03540
- Sifa University Medical Faculty
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Seoul, Korea, Republikken, 156-755
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Seoul, Korea, Republikken, 03080
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Seoul, Korea, Republikken, 156-707
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Gyeonggido
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Bucheon-si, Gyeonggido, Korea, Republikken, 420-767
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Bialystok, Polen, 15-540
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Malbork, Polen, 82-200
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Poznan, Polen, 61-858
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Radom, Polen, 26-610
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Szczecin, Polen, 70-111
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Zyrardow, Polen, 96-300
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Bucharest, Rumænien, 020475
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Constanta, Rumænien, 900591
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Oradea, Rumænien, 410469
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Targu-Mures, Rumænien, 540103
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A Coruña
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Santiago de Compostela, A Coruña, Spanien, 15706
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
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Baden-Württemberg
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Villingen-Schwenningen, Baden-Württemberg, Tyskland, 78052
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Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, Tyskland, 53127
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Düsseldorf, Nordrhein-Westfalen, Tyskland, 40210
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Sachsen-Anhalt
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Halle (Saale), Sachsen-Anhalt, Tyskland, 06097
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Baja, Ungarn, 6500
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Budapest, Ungarn, 1036
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Pecs, Ungarn, 7623
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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
Beskrivelse
Inclusion Criteria:
- Women without childbearing potential
- Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
- Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] 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)
- Not treated with any erythropoiesis-stimulating agent (ESA) within 8 weeks before randomization
- Mean screening Hb concentration </= 10.5 g/dL
- Body weight of 45 kg to 125 kg, inclusive, at screening
Exclusion Criteria:
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
- 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
- Subjects treated with any ESA within the 8 weeks before randomization
- Red blood cell (RBC) containing transfusion within the 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 initial screening visit
- Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, third degree atrioventricular [AV] block)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B and C) or active hepatitis, in the investigator's opinion
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: BAY85-3934 (25mg OD)
25 mg once daily (OD) of BAY85-3934 Morning: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Evening: 3 tablets matching placebo
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Matchende placebotablet
25mg Tablet
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Eksperimentel: BAY85-3934 (50mg OD)
50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo
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Matchende placebotablet
25mg Tablet
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Eksperimentel: BAY85-3934 (75mg OD)
75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo
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Matchende placebotablet
25mg Tablet
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Eksperimentel: BAY85-3934 (25mg BID)
25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo
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Matchende placebotablet
25mg Tablet
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Eksperimentel: BAY85-3934 (50mg BID)
50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo
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Matchende placebotablet
25mg Tablet
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Placebo komparator: Placebo BID
Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg
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Matchende placebotablet
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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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
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Baseline and week 12 to 16
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Number of participants with serious adverse events as a measure of safety and tolerability
Tidsramme: Up to 16 weeks
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Up to 16 weeks
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Change in local laboratory hemoglobin level from baseline
Tidsramme: Baseline up to 12 weeks
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Baseline up to 12 weeks
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Speed of change in hemoglobin level per unit time
Tidsramme: Up to 16 weeks
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Up to 16 weeks
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Duration of treatment exposure
Tidsramme: Up to 16 weeks
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Up to 16 weeks
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Pharmacodynamics characterized by erythropoietin concentration
Tidsramme: Several time points up to 16 weeks
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Several time points up to 16 weeks
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Pharmacodynamics characterized by reticulocyte count
Tidsramme: Several time points up to 16 weeks
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Several time points up to 16 weeks
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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 (Faktiske)
10. februar 2014
Primær færdiggørelse (Faktiske)
15. september 2015
Studieafslutning (Faktiske)
23. september 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)
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
- 15141
- 2013-001193-14 (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 .