15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
NCT ID: NCT02021370
Last Updated: 2019-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2014-02-10
2015-09-23
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
BAY85-3934
25mg Tablet
Placebo
Matching placebo tablet
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
BAY85-3934
25mg Tablet
Placebo
Matching placebo tablet
BAY85-3934 (75mg OD)
75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo
BAY85-3934
25mg Tablet
Placebo
Matching placebo tablet
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
BAY85-3934
25mg Tablet
Placebo
Matching placebo tablet
BAY85-3934 (50mg BID)
50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo
BAY85-3934
25mg Tablet
Placebo
Matching placebo tablet
Placebo BID
Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg
Placebo
Matching placebo tablet
Interventions
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BAY85-3934
25mg Tablet
Placebo
Matching placebo tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Gosford, New South Wales, Australia
Melbourne, Victoria, Australia
Gabrovo, , Bulgaria
Lovech, , Bulgaria
Montana, , Bulgaria
Pazardzhik, , Bulgaria
Stara Zagora, , Bulgaria
Veliko Tarnovo, , Bulgaria
Limoges Cedex1, , France
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Bonn, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Halle, Saxony-Anhalt, Germany
Baja, , Hungary
Budapest, , Hungary
Pécs, , Hungary
Ashkelon, , Israel
Hadera, , Israel
Nahariya, , Israel
Napoli, Campania, Italy
Modena, Emilia-Romagna, Italy
Cremona, Lombardy, Italy
Pavia, Lombardy, Italy
Livorno, Tuscany, Italy
Kitakyushu, Fukuoka, Japan
Ōkawa, Fukuoka, Japan
Muroran, Hokkaido, Japan
Hakusan, Ishikawa-ken, Japan
Morioka, Iwate, Japan
Kamakura, Kanagawa, Japan
Kuwana, Mie-ken, Japan
Chiba, , Japan
Fukuoka, , Japan
Nara, , Japan
Bialystok, , Poland
Malbork, , Poland
Poznan, , Poland
Radom, , Poland
Szczecin, , Poland
Żyrardów, , Poland
Bucharest, , Romania
Constanța, , Romania
Oradea, , Romania
Târgu Mureş, , Romania
Bucheon-si, Gyeonggido, South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Santiago de Compostela, A Coruña, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Ankara Univ. Medical Faculty
Ankara, , Turkey (Türkiye)
Baskent University Medical Faculty
Ankara, , Turkey (Türkiye)
Sifa University Medical Faculty
Izmir, , Turkey (Türkiye)
Cambridge, Cambridgeshire, United Kingdom
Doncaster, South Yorkshire, United Kingdom
London, , United Kingdom
Countries
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References
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Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Related Links
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Click here to find results for studies related to Bayer products
Other Identifiers
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2013-001193-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15141
Identifier Type: -
Identifier Source: org_study_id
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