Anemia of Chronic Kidney DiseasePhase 3NCT03521713
To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)
A Phase 3 study testing EPORON and EPREX in people with Anemia of Chronic Kidney Disease, run by Dong-A ST Co., Ltd. at 1 site in Turkey (Türkiye).
Trial summary
This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients. A total of 214 patients will be enrolled in Turkey. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- EPORON and EPREX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2016to Mar 2021
- Phase
- Phase 3
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glomerular Filtration Rate <60 mL/min/1.73m2 (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
- Hemoglobin (Hb) level in the range of ≥7 g/dL and <10 g/dL at screening
- Erythropoiesis Stimulating Agent (ESA) naïve subjects or previously treated subjects with ESA-free period of >3 months (in case of pre-treatment with long-acting ESA such as pegylated epoetin, the long-acting ESA-free period of >6 months)
Who cannot join
- Subjects who have received steady dialysis or subjects who are currently on dialysis
- Subjects who have rapid progression of chronic renal failure (as per investigators' discretion; e.g., a GFR decrease of >20% within 12 weeks prior to screening)
- Subjects who have already undergone renal transplantation or who are scheduled for renal transplantation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Medical Faculty
Ankara, 06560
Turgay Arinsoy, M.D
About this study
Official title: A Randomized, Active Comparator-Controlled, Parallel-Group, Single-Blind, Multicenter, Phase III Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex) in the Treatment of Anemia Associated With Chronic Renal Failure in Pre-dialysis Patients
This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients. A total of 214 patients will be enrolled in Turkey.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- EPORON, EPREX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPORONDrug
Also called Erythropoietin Alpha
- Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL
- Formulation : Solution in PFS
EPREXDrug
Also called Erythropoietin Alpha
- Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL
- Formulation : Solution in PFS
| Study group | Role | What they receive |
|---|---|---|
| EPORON | Experimental | <Part 1 Treatment Period> Week 1 to Week 24 Initial Phase (Week 1 to Week 4) : 50 IU/kg of Erythropoietin Alpha, three times a week (3 x 50 IU/kg/week) No dose adjustments will be permitted during the first 4 weeks of the study. Maintenance Phase (Week 5 to Week 24) The dose will be adjusted to maintain Hb levels between 10 and 12 g/dL.
<Part 2 Treatment Period> : Week 25 to Week 52 The dose of Erythropoietin Alpha will be adjusted to maintain hemoglobin levels between 10 and 12 g/dL as subcutaneous administration in accordance with the given dosing algorithm. The further details are the same as those for maintenance phase of Part 1 Treatment Period. Receives: Drug: EPORON |
| EPREX | Active comparator | <Part 1 Treatment Period> Week 1 to Week 24 Initial Phase (Week 1 to Week 4) : 50 IU/kg of Erythropoietin Alpha, three times a week (3 x 50 IU/kg/week) No dose adjustments will be permitted during the first 4 weeks of the study. Maintenance Phase (Week 5 to Week 24) The dose will be adjusted to maintain Hb levels between 10 and 12 g/dL.
<Part 2 Treatment Period> : Week 25 to Week 52 The dose of Erythropoietin Alpha will be adjusted to maintain hemoglobin levels between 10 and 12 g/dL as subcutaneous administration in accordance with the given dosing algorithm. The further details are the same as those for maintenance phase of Part 1 Treatment Period. Receives: Drug: EPREX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Change in Hb levels
The primary endpoint is the mean absolute change in Hb levels between the screening/baseline period (Week -2 to Day 1 of Week 1) and the evaluation period (Week 21 to Week 24).
Hb level at screening/baseline period is defined as the mean of the Hb measurements at screening and on Day 1 of Week 1 (prior to dosing). Hb level at evaluation period is defined as the mean of the Hb measurements at Week 21, 22, 23, and 24 (in detail, Day 1 of Week 21, Day 1 of Week 22, Day 1 of Week 23, and Day 1 of Week 24).
Measured: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Secondary outcomes (3)
Hemoglobin Responder Rate
Measured: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Mean EPO dosage (Week 1 to Week 24)
Measured: Week 1 ~ Week 24
Mean EPO dosage (Week 21 to Week 24)
Measured: Week 21 ~ Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Mar 2016
- Primary completionSep 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Turgay Arinsoy, MD, Study chair, Gazi University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521713
- Sponsor's protocol ID
- DAEPO_ANE_III
- Status last verified
- Dec 2019
- First submitted
- 21 Feb 2017
- Last updated
- 10 Dec 2019
- 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 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active Comparator-Controlled, Parallel-Group, Single-Blind, Multicenter, Phase III Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex) in the Treatment of Anemia Associated With Chronic Renal Failure in Pre-dialysis Patients
- ClinicalTrials.gov ID
- NCT03521713
- Acronym / sponsor ID
- DAEPO_ANE_III
- Conditions
- Anemia of Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 11 May 2018 (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.
This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients. A total of 214 patients will be enrolled in Turkey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPORON | Experimental | Drug: EPORON<Part 1 Treatment Period> Week 1 to Week 24 Initial Phase (Week 1 to Week 4) : 50 IU/kg of Erythropoietin Alpha, three times a week (3 x 50 IU/kg/week) No dose adjustments will be permitted during the first 4 weeks of the study. Maintenance Phase (Week 5 to Week 24) The dose will be adjusted to maintain Hb levels between 10 and 12 g/dL. <Part 2 Treatment Period> : Week 25 to Week 52 The dose of Erythropoietin Alpha will be adjusted to maintain hemoglobin levels between 10 and 12 g/dL as subcutaneous administration in accordance with the given dosing algorithm. The further details are the same as those for maintenance phase of Part 1 Treatment Period. |
| EPREX | Active comparator | Drug: EPREX<Part 1 Treatment Period> Week 1 to Week 24 Initial Phase (Week 1 to Week 4) : 50 IU/kg of Erythropoietin Alpha, three times a week (3 x 50 IU/kg/week) No dose adjustments will be permitted during the first 4 weeks of the study. Maintenance Phase (Week 5 to Week 24) The dose will be adjusted to maintain Hb levels between 10 and 12 g/dL. <Part 2 Treatment Period> : Week 25 to Week 52 The dose of Erythropoietin Alpha will be adjusted to maintain hemoglobin levels between 10 and 12 g/dL as subcutaneous administration in accordance with the given dosing algorithm. The further details are the same as those for maintenance phase of Part 1 Treatment Period. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Glomerular Filtration Rate <60 mL/min/1.73m2 (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
- Hemoglobin (Hb) level in the range of ≥7 g/dL and <10 g/dL at screening
- Erythropoiesis Stimulating Agent (ESA) naïve subjects or previously treated subjects with ESA-free period of >3 months (in case of pre-treatment with long-acting ESA such as pegylated epoetin, the long-acting ESA-free period of >6 months)
Key exclusion criteria (3 listed)
- Subjects who have received steady dialysis or subjects who are currently on dialysis
- Subjects who have rapid progression of chronic renal failure (as per investigators' discretion; e.g., a GFR decrease of >20% within 12 weeks prior to screening)
- Subjects who have already undergone renal transplantation or who are scheduled for renal transplantation
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 |
|---|---|---|
| EPORONAlso: Erythropoietin Alpha* Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL * Formulation : Solution in PFS | Drug | EPORON |
| EPREXAlso: Erythropoietin Alpha* Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL * Formulation : Solution in PFS | Drug | EPREX |
Primary outcome
Mean Absolute Change in Hb levels
Time frame: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
The primary endpoint is the mean absolute change in Hb levels between the screening/baseline period (Week -2 to Day 1 of Week 1) and the evaluation period (Week 21 to Week 24). Hb level at screening/baseline period is defined as the mean of the Hb measurements at screening and on Day 1 of Week 1 (prior to dosing). Hb level at evaluation period is defined as the mean of the Hb measurements at Week 21, 22, 23, and 24 (in detail, Day 1 of Week 21, Day 1 of Week 22, Day 1 of Week 23, and Day 1 of Week 24).
3 secondary outcomes
Hemoglobin Responder Rate
Time frame: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Mean EPO dosage (Week 1 to Week 24)
Time frame: Week 1 ~ Week 24
Mean EPO dosage (Week 21 to Week 24)
Time frame: Week 21 ~ Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- 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.
Turgay Arinsoy, MD study chair
Gazi University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EPORON and EPREX in people with Anemia of Chronic Kidney Disease, run by Dong-A ST Co., Ltd. at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Dec 2019. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayse Uslu (90 312 284 50 85, ayse.uslu@triogrup-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Change in Hb levels (time frame: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24). 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 10 Dec 2019.