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

Study Overview
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Brief Summary
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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
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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end of the study is the last day of the Blood sample will be drawn In the case of a subject that has left the study (withdrawn), the exit date will be the end of the study.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.

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

Conditions
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Chronic Kidney Disease (CKD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have anemia associated with Chronic Kidney Disease (CKD) under hemodialysis treatment. Male or female patients aged ≥18 years. Patients with mean Hb concentration when screening is around ≤10 g/dL. Patients on stable, adequate dialysis for at least three months (defined as no clinically relevant changes of hemodialysis regimen and/or 23/42 ©EMEA 2007 dialyzer). Has ever been using Epodion treatment in the at least last 1 month. Haemodialysis patients who likely to remain on Epodion treatment for 52 weeks. Informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug. Exclusion Criteria: History of Pure Red Cell Aplasia (PRCA) or anti-epoetin antibodies. Contraindications for ESA therapy. Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level. History of uncontrolled hypertension (defined as systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg during screening). Any blood transfusion within the last 2 weeks prior to screening period. Major surgery within 3 months prior to screening period. Myelodysplastic syndrome. History bleeding disorders (e.g. Hemophilia, Von Willebrand, and any conditions that result when the blood cannot clot properly). Known bone marrow fibrosis (osteitis fibrosa cystica). Known epilepsy. Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites). Systemic lupus erythematosus. Previously diagnosed with HIV or acute hepatitis infection. History of malignancy of any organ system within the last 5 year. Pregnancy or lactation period in female patients. Heavy smoker (who smoke over 20 cigarettes daily in average).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br>Experimental: Test Drug Recombinant Human Erythropoietin Alfa | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 52nd | to evaluate if there is any incidence of ADA formation on the blood sample | week 52 | 
| Neutralizing Antibodies detection (Nab) (will be assessed if ADA is positive). | to evaluate the neutralizing effect of the detected ADA using cell-based assay method to confirm the impact of the antibody to pharmacological activity. | week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any Adverse Event | to evaluate any adverse event related to the test product during study | 52 weeks | 
| Incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 24th | to evaluate if there is any incidence of ADA formation on the blood sample | week 24 | 
| Comparison on the incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 24th and week 52nd. | to evaluate the neutralizing effect of the detected ADA using cell-based assay method to confirm the impact of the antibody to pharmacological activity. | week 24 and 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rh-EPO, Chronic Kidney Disease, Erythropoietin alpha