| Trial ID: | L0455 |
| Source ID: | NCT02044653
|
| Associated Drug: |
Gx-E2
|
| Title: |
Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia|Chronic Kidney Disease
|
| Interventions: |
DRUG: GX-E2|DRUG: GX-E2|DRUG: GX-E2|DRUG: NESP|DRUG: MIRCERA
|
| Outcome Measures: |
Primary: average change of Hemoglobin level, change from baseline in Hemoglobin level, 6 weeks (Part A) & 14 weeks (Part B) | Secondary: change of red blood cell indices, change from baseline in red blood cell indices, 6 weeks (Part A) & 14 weeks (Part B)|change of reticulocyte indices, change from baseline in reticulocyte indices, 6 weeks (Part A) & 14 weeks (Part B)|incidence, degree, outcome of adverse event, Incidence of adverse events, 6 weeks (Part A) & 14 weeks (Part B)|incidence, frequency, amount of blood transfusion, Incidence of adverse events, 6 weeks (Part A) & 14 weeks (Part B)|immunogenicity: ratio of neutralizing antibody & binding antibody in subjects, comparison from pre-treatment to post-treatment, 6 weeks (Part A) & 14 weeks (Part B)
|
| Sponsor/Collaborators: |
Sponsor: Genexine, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
257
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-04-15
|
| Completion Date: |
2017-04-20
|
| Results First Posted: |
|
| Last Update Posted: |
2017-10-16
|
| Locations: |
Bucheon St. Mary's Hospital, Bucheon, Korea, Republic of|Bundang Seoul National University College of Medicine, Gumi, Korea, Republic of|The Catholic University of Korea Incheon St.Mary's Hospital, Incheon, Korea, Republic of|Gangnam severance hospital, Seoul, Korea, Republic of|Seoul St.Mary's Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02044653
|
