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Clinical Trial Details

Trial ID: L0682
Source ID: NCT03521713
Associated Drug: Eporon
Title: To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Anemia of Chronic Kidney Disease
Interventions: DRUG: EPORON|DRUG: EPREX
Outcome Measures: Primary: Mean Absolute Change in Hb levels, The primary endpoint is the mean absolute change in Hb levels between the screening/baseline period (Week -2 to Day 1 of Week 1) and the evaluation period (Week 21 to Week 24). Hb level at screening/baseline period is defined as the mean of the Hb measurements at screening and on Day 1 of Week 1 (prior to dosing). Hb level at evaluation period is defined as the mean of the Hb measurements at Week 21, 22, 23, and 24 (in detail, Day 1 of Week 21, Day 1 of Week 22, Day 1 of Week 23, and Day 1 of Week 24)., Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24 | Secondary: Hemoglobin Responder Rate, Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24|Mean EPO dosage (Week 1 to Week 24), Week 1 ~ Week 24|Mean EPO dosage (Week 21 to Week 24), Week 21 ~ Week 24 | Other: Safety: Any adverse events, Any adverse events, Week 1 to Week 52|Immunogenicity: Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2~Week 1 (Prior to Dose)), Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2\~Week 1 (Prior to Dose)), (Week -2~Week 1 (Prior to Dose)), Week 52
Sponsor/Collaborators: Sponsor: Dong-A ST Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 214
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-03-01
Completion Date: 2021-03
Results First Posted:
Last Update Posted: 2019-12-10
Locations: Gazi University Medical Faculty, Ankara, 06560, Turkey
URL: https://clinicaltrials.gov/show/NCT03521713