Clinical Trial Details
| Trial ID: | L1357 |
| Source ID: | NCT01964196 |
| Associated Drug: | Asp1517 |
| Title: | ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis- |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Anemia in Chronic Kidney Disease Patients Not on Dialysis |
| Interventions: | DRUG: ASP1517|DRUG: Placebo |
| Outcome Measures: | Primary: Rate of rise in Hb (g/dL/week) at Week 6, Baseline and at 6 weeks after dosing | Secondary: Percentage of cumulative number of responder patients, responder is defined as a Hb ≥10.0 g/dL and an increase in Hb by ≥1.0 g/dL, for 28 weeks after dosing|Percentage of visits at which patients maintain Hb between 10.0-12.0 g/dL after achieving Hb ≥10.0 g/dL for each patients, for 28 weeks after dosing|Percentage of patients who maintain Hb between 10.0-12.0 g/dL at each visit, Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28|Change from baseline in Hb, Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28|Safety assessed as the incidence of adverse events, vital signs, 12-lead ECGs and lab-tests, for 28 weeks after dosing |
| Sponsor/Collaborators: | Sponsor: Astellas Pharma Inc |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 107 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-09-17 |
| Completion Date: | 2015-12-01 |
| Results First Posted: | |
| Last Update Posted: | 2024-10-30 |
| Locations: | Chubu, Japan|Hokkaido, Japan|Kansai, Japan|Kanto, Japan|Kyushu, Japan|Shikoku, Japan|Tohoku, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01964196 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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