| Trial ID: | L0448 |
| Source ID: | NCT02586402
|
| Associated Drug: |
Pegol-Sihematide
|
| Title: |
Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Failure|Anemia|Dialysis
|
| Interventions: |
DRUG: pegol-Sihematide|DRUG: Epoetin Alfa
|
| Outcome Measures: |
Primary: Average reticulocytes and hemoglobin change from baseline, Baseline to Week 16 | Secondary: Proportion of patients whose Hb within ±1.0 g/dL of baseline during Weeks 12 to 16, week 12 to 16|Average RBC, hematokrit and reticulocytes change from baseline, Baseline to Week 16|Proportion of patients whose Hb levels were maintained within 10 to 12.0g/dL during Weeks 12 to 16, week 12 to 16|Incidence of adverse events and serious adverse events, Baseline to Week 16
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-10
|
| Completion Date: |
2016-08
|
| Results First Posted: |
|
| Last Update Posted: |
2015-10-26
|
| Locations: |
Changzheng Hospital, Shanghai, Shanghai, 200003, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02586402
|
