Long-term Pre-dialysis Extension in Europe and Asia Pacific
NCT ID: NCT02055482
Last Updated: 2017-11-22
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
166 participants
INTERVENTIONAL
2014-06-24
2016-12-12
Brief Summary
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The purpose of this extension 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 extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 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. This study will include subjects who either completed the treatment period in their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension study.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BAY85-3934
Molidustat (BAY85-3934)
BAY85-3934 will be titrated at the scheduled dose control visits to maintain the Hb in the target range of 10.0 to 12.0 g/dL. Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD. Treatment will be for minimum of 6 months to up to a maximum of 36 months.
Darbepoetin
Darbepoetin
Darbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection. Treatment will be for a minimum of 6 months to up to a maximum of 36 months.
Interventions
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Molidustat (BAY85-3934)
BAY85-3934 will be titrated at the scheduled dose control visits to maintain the Hb in the target range of 10.0 to 12.0 g/dL. Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD. Treatment will be for minimum of 6 months to up to a maximum of 36 months.
Darbepoetin
Darbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection. Treatment will be for a minimum of 6 months to up to a maximum of 36 months.
Eligibility Criteria
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Inclusion Criteria
* Not on dialysis at study entry
* Serum ferritin levels ≥ 100 μg/L and \< 1000 μg/L or transferrin saturation ≥ 20%
Exclusion Criteria
* Red blood cell (RBC) containing transfusion within the 8 weeks before baseline
* Phosphodiesterase type 5 (PDE5) inhibitor (e.g., sildenafil, vardenafil, tadalafil) or nitrates
* Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure ≥ 180/110 mmHg or systolic blood pressure \< 95 mmHg, respectively
* Severe rhythm or conduction disorders (e.g., heart rate \[HR\] \< 50 or \> 110 bpm, atrial flutter, prolonged QT \> 500 msec, second or third degree atrioventricular \[AV\] block), if not reacted with a pace marker)
* New York Heart Association Class III or IV congestive heart failure
* Severe hepatic insufficiency (defined as alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]\>3x 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
* An ongoing serious adverse event (SAE) from Study 15141 or Study 15261 that is assessed as related to study drug
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
Reservoir, , Australia
Burgas, , Bulgaria
Dobrich, , Bulgaria
Gabrovo, , Bulgaria
Karlovo, , Bulgaria
Lovech, , Bulgaria
Montana, , Bulgaria
Pazardzhik, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Veliko Tarnovo, , Bulgaria
Brest, , France
Grenoble, , France
Limoges Cedex1, , France
Pierre-Bénite, , France
Valenciennes, , France
Pirmasens, Baden-Wurttemberg, Germany
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Bonn, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Halle, Saxony-Anhalt, Germany
Berlin, , Germany
Wuppertal, , Germany
Baja, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Esztergom, , Hungary
Kaposvár, , Hungary
Pécs, , Hungary
Szigetvár, , Hungary
Ashkelon, , Israel
Hadera, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Nahariya, , Israel
Chieti, Abruzzo, Italy
Napoli, Campania, Italy
Modena, Emilia-Romagna, Italy
Brescia, Lombardy, Italy
Cremona, Lombardy, Italy
Lecco, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Livorno, Tuscany, Italy
Kitakyushu, Fukuoka, Japan
Ōkawa, Fukuoka, Japan
Muroran, Hokkaido, Japan
Hakusan, Ishikawa-ken, Japan
Morioka, Iwate, Japan
Fujisawa, Kanagawa, Japan
Kamakura, Kanagawa, Japan
Kuwana, Mie-ken, Japan
Chiba, , Japan
Fukuoka, , Japan
Nagano, , Japan
Nara, , Japan
Bialystok, , Poland
Poznan, , Poland
Radom, , Poland
Szczecin, , Poland
Żyrardów, , Poland
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
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
San Sebastián de los Reyes, Madrid, Spain
Alicante, , Spain
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Madrid, , Spain
Madrid, , Spain
Ankara Univ. Medical Faculty
Ankara, , Turkey (Türkiye)
Baskent University Medical Faculty
Ankara, , Turkey (Türkiye)
Sifa University Medical Faculty
Izmir, , Turkey (Türkiye)
Reading, Berkshire, United Kingdom
Cambridge, Cambridgeshire, United Kingdom
Dundee, Dundee City, United Kingdom
Brighton, East Sussex, United Kingdom
Salford, Manchester, United Kingdom
Hexham, Northumberland, United Kingdom
Doncaster, South Yorkshire, United Kingdom
Leeds, West Yorkshire, United Kingdom
Chorley, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2013-001190-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15653
Identifier Type: -
Identifier Source: org_study_id