Trials / Completed
CompletedNCT05422755
The Clinical Study to Evaluate Immunogenicity of Epodion® in Anemia Associated With CKD Patients
A Prospective, Open Label, Single Arm, and Multicenter Study to Evaluate Immunogenicity of Epodion in Anemia Associated With Chronic Kidney Disease (CKD) Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (actual)
- Sponsor
- PT. Daewoong Infion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study was conducted to assess safety and immunogenicity of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority.
Detailed description
This study consisted of a screening period (4 weeks) and treatment period (52 weeks). Evaluation for immunogenicity effect using ADA (Anti Drug Antibody) detection will be done at weeks 0, 24, and 52 and blood sampling for Routine Hematological tests as supporting data will be conducted every month following hospital regulation. For each subject, the end of the study is the last day of the Blood sample will be drawn In the case of a subject that has left the study (withdrawn), the exit date will be the end of the study. The safety evaluation was conducted based on the incidence of the adverse events local and systemic reactions.
Conditions
Timeline
- Start date
- 2019-09-30
- Primary completion
- 2020-11-30
- Completion
- 2020-11-30
- First posted
- 2022-06-16
- Last updated
- 2022-07-22
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT05422755. Inclusion in this directory is not an endorsement.