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Clinical Trial Details

Trial ID: L1081
Source ID: NCT02064426
Associated Drug: Molidustat (Bay85-3934)
Title: Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
Acronym: DIALOGUE5
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia|Renal Insufficiency, Chronic
Interventions: DRUG: Molidustat (BAY85-3934)|BIOLOGICAL: Epoetin alfa/beta
Outcome Measures: Primary: Change in local laboratory hemoglobin level from baseline, Baseline up to 36 months|Number of participants with serious adverse events as a measure of safety and tolerability, Up to 36 months | Secondary: Maintenance in hemoglobin target range (10.0 to 11.0 g/dL), Up to 36 months|Maintenance in hemoglobin target range (9.5 to 11.5 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 reticulocyte count from baseline of study 16208, Baseline up to 36 months|Change of red blood cell count from baseline of this study, Baseline up to 36 months|Change of red blood cell count from baseline of study 16208, Baseline up to 36 months|Change of hematocrit from baseline of this study, Baseline up to 36 months|Change of hematocrit from baseline of study 16208, Baseline up to 36 months|Change of central laboratory hemoglobin level from baseline of this study, Baseline up to 36 months|Change of central laboratory hemoglobin level from baseline of study 16208, Baseline up to 36 months
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 88
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-03-13
Completion Date: 2016-11-16
Results First Posted:
Last Update Posted: 2019-09-20
Locations: Azusa, California, 91702, United States|Long Beach, California, 90813, United States|Lynwood, California, 90262, United States|Northridge, California, 91324, United States|San Dimas, California, 91773, United States|Whittier, California, 90602, United States|Whittier, California, 90606, United States|New Port Richey, Florida, 34652, United States|Pembroke Pines, Florida, 33028, United States|Detroit, Michigan, 48202, United States|Creve Coeur, Missouri, 63141, United States|Buffalo, New York, 14215, United States|Cincinnati, Ohio, 45206, United States|Toledo, Ohio, 43615, United States|Oklahoma City, Oklahoma, 73116, United States|Nashville, Tennessee, 37212-8150, United States|Fort Worth, Texas, 76104, United States|Fort Worth, Texas, 76105, United States|Fort Worth, Texas, 76164, United States|Grand Prairie, Texas, 75050, United States|Houston, Texas, 77004, United States|Houston, Texas, 77091, United States|Mansfield, Texas, 76063, United States|Muroran, Hokkaido, 050-0083, Japan|Kuwana, Mie, 511-0061, Japan|Kyoto, 607-8116, Japan
URL: https://clinicaltrials.gov/show/NCT02064426

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress