Chronic Kidney Disease (CKD)NCT05373303
The Clinical Study for Evaluating The Safety And Efficacy Of Epodion®
A study testing Recombinant Human Erythropoietin Alpha in people with Chronic Kidney Disease (CKD), run by PT. Daewoong Infion at 1 site in Indonesia.
Trial summary
The study was conducted to evaluate whether the efficacy and safety profile 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 to 74 years
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- Recombinant Human Erythropoietin Alpha
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Nov 2019to 28 Jan 2022
- Phase
- Interventional
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients who are at least 18 years old and younger than 75 years of age at the time of screening visit.
- Patients with End-Stage Renal Failure (ESRD) who are chronically receiving hemodialysis and have anemia.
- Patients with a mean baseline Hb concentration within Hb level ≥ 9 g/dL during the screening period.
- Haemodialysis patients with anemia associated with Chronic Kidney Disease (CKD) currently receiving stable maintenance therapy with Epoetin alfa at least once per week
- Adequate iron substitution status (serum ferritin ≥ 100 μg /dl or saturated transferrin levels ≥ 20%).
- Patients who understand the information provided to them or their representatives and may provide written consent.
Who cannot join
- Contraindication with Epoetin therapy.
- Documented active bleeding in the last 12 weeks prior to screening period.
- Any blood transfusion within the last 2 weeks prior Screening period.
- History of malignancy of any organ system within the last 5 years.
- Patients with uncontrolled hypertension (in case the mean value of diastolic blood pressure as measured 4 times during the baseline observation period is 110 mmHg or more).
- Patients hyporesponsive epoetin treatment or had medical history of experiencing pure red blood cell forming failure after being administered with Epoetin products.
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- Known bone marrow fibrosis (osteitis fibrosa cystica).
- Patient with serious cardiovascular disorders: myocardial infarction, patients with congestive heart failure (NYHA class Ⅲ or higher), ischemic vascular disease
- Patient received percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) during the last 6 months prior to screening.
- Patient with the following liver disorder: Patient diagnosed with liver cirrhosis, hepatitis B, or on active treatment hepatitis C, and patients with ALT or AST exceeding the upper limits of the normal level by more than double.
- Patients whose kidney transplant is expected or already planned for survival.
- Secondary anemia to other causes different to the CKD (aplastic anemia, hemolytic anemia, sickle cell anemia, multiple myeloma, leukemia, myelodysplastic syndrome).
- Patients with the following diseases and who are considered unfit to enroll in the clinical study: mental system disease, mental disease, drug intoxication, epilepsy, lung infarction, cerebral infarction, positive HIV antibody, systemic lupus erythematosus, immunosuppressive condition and general infection
- Pregnancy or lactation period in female patients, or women of childbearing potential without an effective method of birth control.
- Patients who were considered unfit for study by the principal investigators or by the co-investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Study for Evaluating The Safety And Efficacy Of Epodion® During Maintenance Period Until Evaluation Period On CKD (Chronic Kidney Disease) Patients: An Open Label, Randomized, Active Drug-Comparative, Parallel-Designed, Multi-Center Clinical Study
The study was conducted to evaluate whether the efficacy and safety profile 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 was an open-label, randomized, active drug-comparative, parallel-designed, multi-center study in hemodialysis patients with anemia.
This study consisted of a screening period (4 weeks), titration period (4~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection. The primary endpoints of efficacy evaluation were to demonstrate that treatment of test product was equivalence with the reference product by evaluating Hb level change between baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40), while the secondary endpoints were to obtain data mean change in weekly dosage per kg body weight between the baseline period and the evaluation period, to calculate instability rate of Hb level during maintenance and evaluation period as defined when Hb level dropped below 8 g/dL or increased by more than 13 g/dL and to evaluate the Hb and hematocrit (Ht) level during maintenance and evaluation period. The safety evaluation was conducted based on the incidence of the adverse events of both local and systemic reactions.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- Recombinant Human 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.
Recombinant Human Erythropoietin AlphaBiological
This study consisted of a screening period (4 weeks), titration period (4~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection
Recombinant Human Erythropoietin AlphaBiological
This study consisted of a screening period (4 weeks), titration period (4~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | Recombinant Human Erythropoietin Alfa, dosage : 50 IU/Kg body weight three times per week, and continued to titrated dose closely to achieve baseline Hb level 10-12g/dL Receives: Biological: Recombinant Human Erythropoietin Alpha |
| Reference Drug | Active comparator | Recombinant Human Erythropoietin Alfa, dosage : 50 IU/Kg body weight three times per week, and continued to titrated dose closely to achieve baseline Hb level 10-12g/dL Receives: Biological: Recombinant Human Erythropoietin Alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb level change
Hb level change between Test and Reference Drug
Measured: baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40).
Secondary outcomes (1)
mean change in weekly dosage per kg body weight
Dosage for Mean change in mg/Kg Body Weight
Measured: baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start7 Nov 2019
- Primary completion15 May 2021
- Study completion28 Jan 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label, randomized, active drug-comparative, parallel-designed
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Daewoong Infion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Equilab International
- Responsible party
- Sponsor
- Investigators
- Jonny Jonny, MD, Principal investigator, Gatot Soebroto Army Hospital, Jakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373303
- Sponsor's protocol ID
- DW_EPO401
- Status last verified
- Jul 2022
- First submitted
- 26 Apr 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study for Evaluating The Safety And Efficacy Of Epodion® During Maintenance Period Until Evaluation Period On CKD (Chronic Kidney Disease) Patients: An Open Label, Randomized, Active Drug-Comparative, Parallel-Designed, Multi-Center Clinical Study
- ClinicalTrials.gov ID
- NCT05373303
- Acronym / sponsor ID
- DW_EPO401
- Conditions
- Chronic Kidney Disease (CKD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- PT. Daewoong InfionIndustry (pharma, biotech, devices)
- Collaborators
- Equilab International
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 13 May 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 evaluate whether the efficacy and safety profile 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 was an open-label, randomized, active drug-comparative, parallel-designed, multi-center study in hemodialysis patients with anemia.
This study consisted of a screening period (4 weeks), titration period (4~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection. The primary endpoints of efficacy evaluation were to demonstrate that treatment of test product was equivalence with the reference product by evaluating Hb level change between baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40), while the secondary endpoints were to obtain data mean change in weekly dosage per kg body weight between the baseline period and the evaluation period, to calculate instability rate of Hb level during maintenance and evaluation period as defined when Hb level dropped below 8 g/dL or increased by more than 13 g/dL and to evaluate the Hb and hematocrit (Ht) level during maintenance and evaluation period. The safety evaluation was conducted based on the incidence of the adverse events of both local and systemic reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, randomized, active drug-comparative, parallel-designed
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Biological: Recombinant Human Erythropoietin AlphaRecombinant Human Erythropoietin Alfa, dosage : 50 IU/Kg body weight three times per week, and continued to titrated dose closely to achieve baseline Hb level 10-12g/dL |
| Reference Drug | Active comparator | Biological: Recombinant Human Erythropoietin AlphaRecombinant Human Erythropoietin Alfa, dosage : 50 IU/Kg body weight three times per week, and continued to titrated dose closely to achieve baseline Hb level 10-12g/dL |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients who are at least 18 years old and younger than 75 years of age at the time of screening visit.
- Patients with End-Stage Renal Failure (ESRD) who are chronically receiving hemodialysis and have anemia.
- Patients with a mean baseline Hb concentration within Hb level ≥ 9 g/dL during the screening period.
- Haemodialysis patients with anemia associated with Chronic Kidney Disease (CKD) currently receiving stable maintenance therapy with Epoetin alfa at least once per week
- Adequate iron substitution status (serum ferritin ≥ 100 μg /dl or saturated transferrin levels ≥ 20%).
Key exclusion criteria (15 listed)
- Contraindication with Epoetin therapy.
- Documented active bleeding in the last 12 weeks prior to screening period.
- Any blood transfusion within the last 2 weeks prior Screening period.
- History of malignancy of any organ system within the last 5 years.
- Patients with uncontrolled hypertension (in case the mean value of diastolic blood pressure as measured 4 times during the baseline observation period is 110 mmHg or more).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Erythropoietin AlphaThis study consisted of a screening period (4 weeks), titration period (4~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection | Biological | Test Drug |
| Recombinant Human Erythropoietin AlphaThis study consisted of a screening period (4 weeks), titration period (4~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection | Biological | Reference Drug |
Primary outcome
Hb level change
Time frame: baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40).
Hb level change between Test and Reference Drug
1 secondary outcome
mean change in weekly dosage per kg body weight
Time frame: baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40).
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 14 Jul 2022.
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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.
Jonny Jonny, MD principal investigator
Gatot Soebroto Army Hospital, Jakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Human Erythropoietin Alpha in people with 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 6 inclusion and 15 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 14 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?
Hb level change (time frame: baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40).). 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 14 Jul 2022.