| Trial ID: | L0756 |
| Source ID: | NCT01888445
|
| Associated Drug: |
Roxadustat
|
| Title: |
A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Anemia Associated With Chronic Renal Failure (CRF)
|
| Interventions: |
DRUG: roxadustat|DRUG: darbepoetin alfa
|
| Outcome Measures: |
Primary: Rate of rise in hemoglobin (g/dL/week), Baseline and at Week-6 | Secondary: Cumulative number of responder patients, Responder is defined as a hemoglobin \>10.0 g/dL and an increase in hemoglobin by \>1.0 g/dL from baseline, up to Week-24|Percent of visits at which patients maintain hemoglobin between 10.0-12.0 g/dL after achieving hemoglobin ≥10.0 g/dL for each patients, for 28 weeks after dosing|Percent of patients who maintain hemoglobin between 10.0-12.0 g/dL at each visit, for 28 weeks after dosing
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
130
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-03-28
|
| Completion Date: |
2014-09-15
|
| Results First Posted: |
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| Last Update Posted: |
2024-10-30
|
| Locations: |
Chubu, Japan|Chugoku, Japan|Hokuriku, Japan|Kansai, Japan|Kanto, Japan|Kyushu, Japan|Shikoku, Japan|Tohoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01888445
|
