Chronic Kidney Disease (CKD)NCT05422755
The Clinical Study to Evaluate Immunogenicity of Epodion® in Anemia Associated With CKD Patients
An observational study of Chronic Kidney Disease (CKD), run by PT. Daewoong Infion at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Sep 2019to 30 Nov 2020
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Chronic Kidney Disease (CKD)
- Keywords
- rh-EPO, Chronic Kidney Disease, Erythropoietin alpha
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental: Test Drug Recombinant Human Erythropoietin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 52nd
to evaluate if there is any incidence of ADA formation on the blood sample
Measured: 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.
Measured: week 52
Secondary outcomes (3)
Any Adverse Event
to evaluate any adverse event related to the test product during study
Measured: 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
Measured: 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.
Measured: week 24 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start30 Sep 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- PT. Daewoong Infion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Equilab International
- Responsible party
- Sponsor
- Investigators
- Nova Angginy, Study director, PT. Daewoong Infion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422755
- Sponsor's protocol ID
- DW_EPOC01
- Status last verified
- Jul 2022
- First submitted
- 8 Jun 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05422755
- Acronym / sponsor ID
- DW_EPOC01
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- rh-EPO, Chronic Kidney Disease, Erythropoietin alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- PT. Daewoong InfionIndustry (pharma, biotech, devices)
- Collaborators
- Equilab International
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | –Experimental: Test Drug Recombinant Human Erythropoietin Alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 52nd
Time frame: week 52
to evaluate if there is any incidence of ADA formation on the blood sample
Neutralizing Antibodies detection (Nab) (will be assessed if ADA is positive).
Time frame: week 52
to evaluate the neutralizing effect of the detected ADA using cell-based assay method to confirm the impact of the antibody to pharmacological activity.
3 secondary outcomes
Any Adverse Event
Time frame: 52 weeks
Incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 24th
Time frame: week 24
Comparison on the incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 24th and week 52nd.
Time frame: week 24 and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nova Angginy study director
PT. Daewoong Infion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (CKD), run by PT. Daewoong Infion at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Anti-Erythropoietin Antibodies (ADA) formation at week 52nd (time frame: week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.