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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease (CKD)

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end of the study is the last day of the Blood sample will be drawn In the case of a subject that has left the study (withdrawn), the exit date will be the end of the study.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

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10410
      • Gatot Soebroto Army Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study is conducted on Patients who have anemia associated with Chronic Kidney Disease (CKD) under hemodialysis treatment and Have been using Epodion treatment for at least the last 1 month in several hospitals in Jakarta.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Arm 1; Experimental: Test Drug Recombinant Human Erythropoietin Alfa

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PT. Daewoong Infion
• Collaborators: Equilab International
• Investigators: Study Director: Nova Angginy, PT. Daewoong Infion

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; rh-EPO; Erythropoietin alpha
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: DW_EPOC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No