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Clinical Trial Details

Trial ID: L1242
Source ID: NCT02021370
Associated Drug: Bay85-3934
Title: 15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
Acronym: DIALOGUE 1
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia|Renal Insufficiency, Chronic
Interventions: DRUG: BAY85-3934|DRUG: Placebo
Outcome Measures: Primary: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period, Baseline and week 12 to 16 | Secondary: Change in local laboratory hemoglobin level from baseline, Baseline up to 12 weeks|Speed of change in hemoglobin level per unit time, Up to 16 weeks|Duration of treatment exposure, Up to 16 weeks|Number of participants with serious adverse events as a measure of safety and tolerability, Up to 16 weeks|Pharmacodynamics characterized by erythropoietin concentration, Several time points up to 16 weeks|Pharmacodynamics characterized by reticulocyte count, Several time points up to 16 weeks
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 121
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-02-10
Completion Date: 2015-09-23
Results First Posted:
Last Update Posted: 2019-09-20
Locations: Gosford, New South Wales, 2250, Australia|Melbourne, Victoria, 3052, Australia|Gabrovo, 5300, Bulgaria|Lovech, 5500, Bulgaria|Montana, 3400, Bulgaria|Pazardjik, 4400, Bulgaria|Stara Zagora, 6000, Bulgaria|Veliko Tarnovo, 5000, Bulgaria|Limoges Cedex1, 87042, France|Villingen-Schwenningen, Baden-Württemberg, 78052, Germany|Bonn, Nordrhein-Westfalen, 53127, Germany|Düsseldorf, Nordrhein-Westfalen, 40210, Germany|Halle (Saale), Sachsen-Anhalt, 06097, Germany|Baja, 6500, Hungary|Budapest, 1036, Hungary|Pecs, 7623, Hungary|Ashkelon, 7827804, Israel|Hadera, 3810101, Israel|Nahariya, 2210001, Israel|Napoli, Campania, 80138, Italy|Modena, Emilia-Romagna, 41100, Italy|Cremona, Lombardia, 26100, 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|Kamakura, Kanagawa, 247-8533, Japan|Kuwana, Mie, 511-0061, Japan|Chiba, 260-8712, Japan|Fukuoka, 810-8563, Japan|Nara, 630-8581, 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|Malbork, 82-200, Poland|Poznan, 61-858, Poland|Radom, 26-610, Poland|Szczecin, 70-111, Poland|Zyrardow, 96-300, Poland|Bucharest, 020475, 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|Ankara Univ. Medical Faculty, Ankara, 06100, Turkey|Baskent University Medical Faculty, Ankara, 06490, Turkey|Sifa University Medical Faculty, Izmir, 03540, Turkey|Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom|Doncaster, South Yorkshire, DN2 5LT, United Kingdom|London, SE5 9RS, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02021370

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress