To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)
NCT ID: NCT03521713
Last Updated: 2019-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
214 participants
INTERVENTIONAL
2016-03-01
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
EPORON
* Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL
* Formulation : Solution in PFS
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.
EPREX
* Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL
* Formulation : Solution in PFS
Interventions
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EPORON
* Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL
* Formulation : Solution in PFS
EPREX
* Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL
* Formulation : Solution in PFS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
19 Years
74 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Turgay Arinsoy, MD
Role: STUDY_CHAIR
Gazi University Medical Faculty
Locations
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Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Turgay Arinsoy, M.D
Role: primary
Other Identifiers
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DAEPO_ANE_III
Identifier Type: -
Identifier Source: org_study_id