| Trial ID: | L1076 |
| Source ID: | NCT01596855
|
| Associated Drug: |
Fg-4592
|
| Title: |
Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia in End Stage Renal Disease
|
| Interventions: |
DRUG: FG-4592|DRUG: Epoetin Alfa
|
| Outcome Measures: |
Primary: Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7., Week 7 | Secondary: Number (%) of subjects whose hemoglobin levels are between 9.0 and 13.0 g/dL at Weeks 3, 4, 5, 6 and 7., Week 7|Number (%) of subjects whose hemoglobin levels at Weeks 3, 4, 5, 6 and 7 are greater than or equal to their baseline level., Week 7
|
| Sponsor/Collaborators: |
Sponsor: FibroGen | Collaborators: Ruijin Hospital|RenJi Hospital|Chang Zheng Hospital|Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|Peking University First Hospital|First Affiliated Hospital, Sun Yat-Sen University|First Affiliated Hospital of Zhejiang University|Peking Union Medical College Hospital|Shenzhen People's Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
96
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-09
|
| Completion Date: |
2013-01
|
| Results First Posted: |
|
| Last Update Posted: |
2013-02-04
|
| Locations: |
Peking Union Medical College Hospital, Beijing, China|Peking University First Hospital, Beijing, China|First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China|Zhejiang University No 1. Hospital, Hangzhou, China|Chang Zheng Hospital, Shanghai, China|Renji Hospital, Shanghai, China|RuiJin Hospital, Shanghai, China|XinHua Hospital, Shanghai, China|ShenZhen People's Hospital, Shenzhen, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01596855
|
