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Clinical Trial Details

Trial ID: L0949
Source ID: NCT02021409
Associated Drug: Bay85-3934
Title: Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934
Acronym: DIALOGUE 2
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia|Renal Insufficiency, Chronic
Interventions: DRUG: BAY85-3934|BIOLOGICAL: Darbepoetin alfa
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: Maintenance in hemoglobin target range (10.0 to 12.0 g/dL), Up to 16 weeks|Change in hemoglobin level, Baseline up to 16 weeks|Number of patients with hemoglobin levels outside the target range, Week 12 to 16|Dose level in the evaluation period, Week 12 to 16|Duration of exposure on each dose level, Up to 16 weeks|Number of subjects requiring titration of dose, Up to 16 weeks|Number of participants with serious adverse events as a measure of safety and tolerability, Up to 16 weeks
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 126
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-01-28
Completion Date: 2015-11-23
Results First Posted:
Last Update Posted: 2019-09-19
Locations: Gosford, New South Wales, 2250, Australia|Reservoir, Victoria, 3073, Australia|Dobrich, 9300, Bulgaria|Lovech, 5500, Bulgaria|Montana, 3400, Bulgaria|Pazardjik, 4400, Bulgaria|Sofia, 1872, Bulgaria|Stara Zagora, 6000, Bulgaria|Grenoble Cedex 9, 38043, France|Pierre Benite Cedex, 69495, France|Bonn, Nordrhein-Westfalen, 53127, Germany|Baja, 6500, Hungary|Budapest, 1036, Hungary|Esztergom, 2500, Hungary|Kaposvar, 7400, Hungary|Pecs, 7624, Hungary|Szigetvar, 7900, Hungary|Ashkelon, 7827804, Israel|Hadera, 3810101, Israel|Kfar Saba, 4428164, Israel|Nahariya, 2210001, Israel|Napoli, Campania, 80138, Italy|Brescia, Lombardia, 25123, Italy|Cremona, Lombardia, 26100, Italy|Lecco, Lombardia, 23900, Italy|Pavia, Lombardia, 27100, Italy|Livorno, Toscana, 57023, Italy|Kitakyushu, Fukuoka, 802-8555, Japan|Okawa, Fukuoka, 831-0016, Japan|Muroran, Hokkaido, 050-0083, Japan|Morioka, Iwate, 020-0066, Japan|Fujisawa, Kanagawa, 251-8550, Japan|Kuwana, Mie, 511-0061, Japan|Chiba, 260-8712, Japan|Fukuoka, 810-8563, Japan|Nagano, 388-8004, Japan|Bucheon-si, Gyeonggido, 420-767, Korea, Republic of|Bialystok, 15-540, Poland|Radom, 26-610, Poland|Bucharest, 010731, Romania|Bucharest, 020475, Romania|Oradea, 410469, Romania|Targu-Mures, 540103, Romania|L'Hospitalet de Llobregat, Barcelona, 08907, Spain|San Sebastián de los Reyes, Madrid, 28702, Spain|Madrid, 28007, 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|Liverpool, L7 8XP, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02021409

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress