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

NCT05422755 | Completed

• 1 other identifier: DW_EPOC01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease (CKD)

Keywords

rh-EPO; Chronic Kidney Disease; Erythropoietin alpha

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Any Adverse Event

  52 weeks

• Incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 24th

  week 24

• Comparison on the incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 24th and week 52nd.

  week 24 and 52

Study Arms (1)

Arm 1

Experimental: Test Drug Recombinant Human Erythropoietin Alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PT. Daewoong Infion: lead
• Equilab International: collaborator

Study Sites (1)

Gatot Soebroto Army Hospital

Jakarta, DKI Jakarta, 10410, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples on weeks 0, 24, and 52.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nova Angginy

  PT. Daewoong Infion

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 16, 2022
• Study Start: September 30, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)