To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: EPORON
Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL
Formulation : Solution in PFS
Other Names:
|
| Active Comparator: 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. |
Drug: EPREX
Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL
Formulation : Solution in PFS
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Absolute Change in Hb levels [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).
Secondary Outcome Measures
- Hemoglobin Responder Rate [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) [Week 1 ~ Week 24]
- Mean EPO dosage (Week 21 to Week 24) [Week 21 ~ Week 24]
Other Outcome Measures
- Safety: Any adverse events [Week 1 to Week 52]
Any adverse events
- Immunogenicity: Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2~Week 1 (Prior to Dose)) [(Week -2~Week 1 (Prior to Dose)), Week 52]
Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2~Week 1 (Prior to Dose))
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gazi University Medical Faculty | Ankara | Turkey | 06560 |
Sponsors and Collaborators
- Dong-A ST Co., Ltd.
Investigators
- Study Chair: Turgay Arinsoy, MD, Gazi University Medical Faculty
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DAEPO_ANE_III