To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)

Dong-A ST

Status and phase: Unknown; Phase 3

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: EPREX; Drug: EPORON

Study type: Interventional

Funder types: Industry

Identifiers

NCT03521713

DAEPO_ANE_III

Details and patient eligibility

About

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.

Enrollment: 214 estimated patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups

EPORON

Experimental group

Description:

<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.

Treatment:

Drug: EPORON

EPREX

Active Comparator group

Description:

<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.

Treatment:

Drug: EPREX