| Trial ID: | L0432 |
| Source ID: | NCT02403362
|
| Associated Drug: |
Epo-018b
|
| Title: |
Safety & Efficacy of EPO-018B for the Treatment of Anemia in Participants With Chronic Kidney Diseases Not on Dialysis
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Failure|Chronic Kidney Disease|Anemia
|
| Interventions: |
DRUG: EPO-018B
|
| Outcome Measures: |
Primary: Percentage of participants who achieved a target hemoglobin response during the study, A target hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline and a hemoglobin value ≥ 10.0 g/dL during the study, Baseline to Week 24 | Secondary: Percentage of participants who response to study drug, Hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline during the study, Baseline to Week 24|Average reticulocytes change from baseline, Baseline to Week 24|Average hemoglobin change from baseline, Baseline to Week 24|Incidence of adverse events, Baseline to Week 24|Incidence of serious adverse events, Baseline to Week 24
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-06
|
| Completion Date: |
2015-10
|
| Results First Posted: |
|
| Last Update Posted: |
2015-03-31
|
| Locations: |
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510080, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02403362
|
