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Clinical Trial Details

Trial ID: L1207
Source ID: NCT02055482
Associated Drug: Molidustat (Bay85-3934)
Title: Long-term Pre-dialysis Extension in Europe and Asia Pacific
Acronym: DIALOGUE 3
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia|Renal Insufficiency, Chronic
Interventions: DRUG: Molidustat (BAY85-3934)|BIOLOGICAL: Darbepoetin
Outcome Measures: Primary: Change in local laboratory hemoglobin level from baseline, Baseline up to 36 months|Number of participants with serious adverse events (SAEs) and adjucated adverse events as a measure of safety and tolerability, Up to 36 months|Number of participants with liver function-related AEs including abnormal liver function tests and any hospitalization, Up to 36 months | Secondary: Time within hemoglobin target range (10.0 to 12.0 g/dL), Up to 36 months|Duration of treatment exposure, Up to 36 months|Number of subjects requiring titration of dose, Up to 36 months|Change of reticulocyte count from baseline of this study, Baseline up to 36 months|Change of red blood cell count from baseline of this study, Baseline up to 36 months|Change of hematocrit from baseline of this study, Baseline up to 36 months|Change of central laboratory hemoglobin level from baseline of this study, Baseline up to 36 months|Responders in Hb levels, Up to 36 months|Number of subjects meeting specific Hb criteria, Baseline up to 36 months|Number of subjects with Hb values >13 g/dL or having excessive Hb increase, Baseline up to 36 months|Number of participants with non-serious adverse events, Up to 36 months|Change in heart rate (HR), Up to 36 months|Change in blood pressure (BP), Up to 36 months|Laboratory abnormalities, Up to 36 months | Other: Change of reticulocyte count from baseline of study 15141 or 15261, Baseline up to 36 months|Change of red blood cell count from baseline of study 15141 or 15261, Baseline up to 36 months|Change of hematocrit from baseline of study 15141 or 15261, Baseline up to 36 months|Change of central laboratory hemoglobin level from baseline of study 15141 or 15261, Baseline up to 36 months
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 166
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-06-24
Completion Date: 2016-12-12
Results First Posted:
Last Update Posted: 2017-11-22
Locations: Gosford, New South Wales, 2250, Australia|Melbourne, Victoria, 3052, Australia|Reservoir, 3073, Australia|Burgas, 8000, Bulgaria|Dobrich, 9300, Bulgaria|Gabrovo, 5300, Bulgaria|Karlovo, 4300, Bulgaria|Lovech, 5500, Bulgaria|Montana, 3400, Bulgaria|Pazardjik, 4400, Bulgaria|Sofia, 1309, Bulgaria|Sofia, 1431, Bulgaria|Sofia, 1527, Bulgaria|Sofia, 1872, Bulgaria|Stara Zagora, 6000, Bulgaria|Veliko Tarnovo, 5000, Bulgaria|Brest Cedex, 29609, France|Grenoble Cedex 9, 38043, France|Limoges Cedex1, 87042, France|Pierre Benite Cedex, 69495, France|Valenciennes, 59300, France|Pirmasens, Baden-Württemberg, 66953, Germany|Villingen-Schwenningen, Baden-Württemberg, 78052, Germany|Bonn, Nordrhein-Westfalen, 53127, Germany|Düsseldorf, Nordrhein-Westfalen, 40210, Germany|Halle (Saale), Sachsen-Anhalt, 06097, Germany|Berlin, 12053, Germany|Wuppertal, 42283, Germany|Baja, 6500, Hungary|Budapest, 1036, Hungary|Debrecen, 4032, Hungary|Esztergom, 2500, Hungary|Kaposvar, 7400, Hungary|Pecs, 7624, Hungary|Szigetvar, 7900, Hungary|Ashkelon, 7827804, Israel|Hadera, 3810101, Israel|Jerusalem, 9112001, Israel|Kfar Saba, 4428164, Israel|Nahariya, 2210001, Israel|Chieti, Abruzzo, 66013, Italy|Napoli, Campania, 80138, Italy|Modena, Emilia-Romagna, 41100, Italy|Brescia, Lombardia, 25123, Italy|Cremona, Lombardia, 26100, Italy|Lecco, Lombardia, 23900, Italy|Milano, Lombardia, 20132, Italy|Milano, Lombardia, 20162, Italy|Pavia, Lombardia, 27100, Italy|Livorno, Toscana, 57023, Italy|Kitakyushu, Fukuoka, 802-8555, Japan|Okawa, Fukuoka, 831-0016, Japan|Muroran, Hokkaido, 050-0083, Japan|Hakusan, Ishikawa, 924-8588, Japan|Morioka, Iwate, 020-0066, Japan|Fujisawa, Kanagawa, 251-8550, Japan|Kamakura, Kanagawa, 247-8533, Japan|Kuwana, Mie, 511-0061, Japan|Chiba, 260-8712, Japan|Fukuoka, 810-8563, Japan|Nagano, 388-8004, Japan|Nara, 631-0846, Japan|Bucheon-si, Gyeonggido, 420-767, Korea, Republic of|Seoul, 03080, Korea, Republic of|Seoul, 156-707, Korea, Republic of|Seoul, 156-755, Korea, Republic of|Bialystok, 15-540, Poland|Poznan, 61-858, Poland|Radom, 26-610, Poland|Szczecin, 70-111, Poland|Zyrardow, 96-300, Poland|Brasov, 500152, Romania|Bucharest, 010731, Romania|Bucharest, 020475, Romania|Bucharest, 050098, Romania|Constanta, 900591, Romania|Oradea, 410469, Romania|Targu-Mures, 540103, Romania|Santiago de Compostela, A Coruña, 15706, Spain|L'Hospitalet de Llobregat, Barcelona, 08907, Spain|San Sebastián de los Reyes, Madrid, 28702, Spain|Alicante, 03010, Spain|Barcelona, 08035, Spain|Barcelona, 08036, Spain|Córdoba, 14004, Spain|Madrid, 28007, Spain|Madrid, 28041, Spain|Ankara Univ. Medical Faculty, Ankara, 06100, Turkey|Baskent University Medical Faculty, Ankara, 06490, Turkey|Sifa University Medical Faculty, Izmir, 03540, Turkey|Reading, Berkshire, RG2 0TG, United Kingdom|Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom|Dundee, Dundee City, DD1 9SY, United Kingdom|Brighton, East Sussex, BN2 5BE, United Kingdom|Salford, Manchester, M5 5AP, United Kingdom|Hexham, Northumberland, NE46 1QJ, United Kingdom|Doncaster, South Yorkshire, DN2 5LT, United Kingdom|Leeds, West Yorkshire, WF3 4PX, United Kingdom|Chorley, PR7 7NA, United Kingdom|Glasgow, G20 OSP, United Kingdom|Liverpool, L22 0LG, United Kingdom|Liverpool, L7 8XP, United Kingdom|London, SE5 9RS, United Kingdom|London, United Kingdom|Manchester, M15 6SX, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02055482

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress