15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific) (DIALOGUE 1)
17. september 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
121
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New South Wales
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Gosford, New South Wales, Australia, 2250
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Victoria
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Melbourne, Victoria, Australia, 3052
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Gabrovo, Bulgaria, 5300
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Lovech, Bulgaria, 5500
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Montana, Bulgaria, 3400
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Pazardjik, Bulgaria, 4400
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Stara Zagora, Bulgaria, 6000
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Veliko Tarnovo, Bulgaria, 5000
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Limoges Cedex1, Frankrike, 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, Italia, 80138
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Emilia-Romagna
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Modena, Emilia-Romagna, Italia, 41100
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Lombardia
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Cremona, Lombardia, Italia, 26100
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Pavia, Lombardia, Italia, 27100
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Toscana
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Livorno, Toscana, Italia, 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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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, Romania, 020475
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Constanta, Romania, 900591
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Oradea, Romania, 410469
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Targu-Mures, Romania, 540103
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A Coruña
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Santiago de Compostela, A Coruña, Spania, 15706
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spania, 08907
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London, Storbritannia, SE5 9RS
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Cambridgeshire
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Cambridge, Cambridgeshire, Storbritannia, CB2 0QQ
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South Yorkshire
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Doncaster, South Yorkshire, Storbritannia, DN2 5LT
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Ankara, Tyrkia, 06100
- Ankara Univ. Medical Faculty
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Ankara, Tyrkia, 06490
- Baskent University Medical faculty
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Izmir, Tyrkia, 03540
- Sifa University Medical Faculty
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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 placebotablett
25mg Tablet
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Eksperimentell: 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 placebotablett
25mg Tablet
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Eksperimentell: 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 placebotablett
25mg Tablet
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Eksperimentell: 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 placebotablett
25mg Tablet
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Eksperimentell: 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 placebotablett
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 placebotablett
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Hva måler studien?
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. februar 2014
Primær fullføring (Faktiske)
15. september 2015
Studiet fullført (Faktiske)
23. september 2015
Datoer for studieregistrering
Først innsendt
20. desember 2013
Først innsendt som oppfylte QC-kriteriene
20. desember 2013
Først lagt ut (Anslag)
27. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15141
- 2013-001193-14 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .