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The Clinical Study to Evaluate Immunogenicity of Epodion® in Anemia Associated With CKD Patients

Chronic Kidney Disease (CKD) Clinical Trial

Official title:
A Prospective, Open Label, Single Arm, and Multicenter Study to Evaluate Immunogenicity of Epodion in Anemia Associated With Chronic Kidney Disease (CKD) Patients

Clinical Trial 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.

Clinical Trial 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end of the study is the last day of the Blood sample will be drawn In the case of a subject that has left the study (withdrawn), the exit date will be the end of the study.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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05422755
Study type Observational [Patient Registry]
Source PT. Daewoong Infion
Contact
Status Completed
Phase
Start date September 30, 2019
Completion date November 30, 2020
View Details
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