Clinical Trial Details
| Trial ID: | L1024 |
| Source ID: | NCT01975818 |
| Associated Drug: | Molidustat (Bay 85-3934) |
| Title: | Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 |
| Acronym: | DIALOGUE4 |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Anemia|Renal Insufficiency, Chronic |
| Interventions: | DRUG: Molidustat (BAY 85-3934)|BIOLOGICAL: Epoetin alfa/beta |
| Outcome Measures: | Primary: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period, Baseline and weeks 14 to 17 | Secondary: Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL), From week 14 to 17|Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL), From week 14 to 17|Change from baseline in Hb during active treatment, Baseline and weeks 14 to 17|Number of patients with hemoglobin levels outside the target range, From week 14 to 17|Dose level in the evaluation period, Up to 16 weeks|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: | 201 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2013-10-28 |
| Completion Date: | 2015-12-15 |
| Results First Posted: | |
| Last Update Posted: | 2019-09-20 |
| Locations: | Azusa, California, 91702, United States|Long Beach, California, 90813, United States|Los Angeles, California, 90025, 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|Detroit, Michigan, 48236, United States|Creve Coeur, Missouri, 63141, United States|Eatontown, New Jersey, 07724, United States|Brooklyn, New York, 11212, United States|Buffalo, New York, 14215, United States|Fresh Meadows, New York, 11365, 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|San Antonio, Texas, 78215, United States|San Antonio, Texas, 78229, United States|Muroran, Hokkaido, 050-0083, Japan|Himeji, Hyogo, 670-0947, Japan|Kuwana, Mie, 511-0061, Japan|Kyoto, 607-8116, Japan|Nagano, 388-8004, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01975818 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|