Clinical Trial Details
| Trial ID: | L1157 |
| Source ID: | NCT03329196 |
| Associated Drug: | Mt-6548 |
| Title: | Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT03329196/results |
| Conditions: | Anemia; Non-dialysis Dependent Chronic Kidney Disease |
| Interventions: | DRUG: MT-6548|DRUG: Darbepoetin alfa |
| 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|Time to Reach the Target Hb Range in Correction Group Only, Up to Week 52|Rate of Increase in Hb Level in Correction Group Only, Up to Week 6 |
| Sponsor/Collaborators: | Sponsor: Mitsubishi Tanabe Pharma Corporation |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 304 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2017-10-30 |
| Completion Date: | 2019-08-09 |
| 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, Kagoshima, Japan|Research site, Kanagawa, Japan|Research site, Kochi, Japan|Research site, Kumamoto, Japan|Research site, Kyoto, Japan|Research site, Miyagi, Japan|Research site, Nagano, Japan|Research site, Nagasaki, Japan|Research site, Nara, Japan|Research site, Niigata, Japan|Research site, Oita, Japan|Research site, Okayama, Japan|Research site, Okinawa, Japan|Research site, Osaka, Japan|Research site, Saga, Japan|Research site, Saitama, Japan|Research site, Shiga, Japan|Research site, Shizuoka, Japan|Research site, Tokyo, Japan|Research site, Toyama, Japan|Research site, Yamanashi, Japan |
| URL: | https://clinicaltrials.gov/show/NCT03329196 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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