Clinical Trial Details
| Trial ID: | L0941 |
| Source ID: | NCT03439137 |
| Associated Drug: | Mt-6548 |
| Title: | Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT03439137/results |
| Conditions: | Anemia; Hemodialysis Dependent Chronic Kidney Disease |
| Interventions: | DRUG: MT-6548|DRUG: Darbepoetin alfa|DRUG: MT-6548-matching placebo|DRUG: Darbepoetin alfa-matching placebo |
| Outcome Measures: | Primary: Mean Hb Level of Week 20 and Week 24, Up to Week 24 | Secondary: Mean Hb Level of Week 48 and Week 52, Up to Week 52|Hb Level at Each Assessment Time Point, Up to Week 52|Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period, Up to Week 52 |
| Sponsor/Collaborators: | Sponsor: Mitsubishi Tanabe Pharma Corporation |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 323 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2018-02-14 |
| Completion Date: | 2019-07-16 |
| Results First Posted: | 2021-04-12 |
| Last Update Posted: | 2023-12-28 |
| Locations: | Research site, Aichi, Japan|Research site, Chiba, Japan|Research site, Fukui, Japan|Research site, Fukuoka, Japan|Research site, Fukushima, Japan|Research site, Gunma, Japan|Research site, Hiroshima, Japan|Research site, Hokkaido, Japan|Research site, Hyogo, Japan|Research site, Ibaraki, Japan|Research site, Kagawa, Japan|Research site, Kagoshima, Japan|Research site, Kanagawa, Japan|Research site, Kumamoto, Japan|Research site, Kyoto, Japan|Research site, Miyagi, Japan|Research site, Nagano, Japan|Research site, Nagasaki, Japan|Research site, Oita, Japan|Research site, Okayama, Japan|Research site, Okinawa, Japan|Research site, Osaka, Japan|Research site, Saitama, Japan|Research site, Shiga, Japan|Research site, Shizuoka, Japan|Research site, Tokushma, Japan|Research site, Tokyo, Japan|Research site, Yamagata, Japan |
| URL: | https://clinicaltrials.gov/show/NCT03439137 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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