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

Last updated: December 9, 2019
Sponsor: Dong-A ST Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Anemia

Chronic Renal Anemia

Treatment

N/A

Clinical Study ID

NCT03521713
DAEPO_ANE_III
  • Ages 19-74
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Glomerular Filtration Rate <60 mL/min/1.73m2 (estimated by Chronic Kidney DiseaseEpidemiology 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 subjectswith ESA-free period of >3 months (in case of pre-treatment with long-acting ESA suchas pegylated epoetin, the long-acting ESA-free period of >6 months)

Exclusion

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 forrenal transplantation

Study Design

Total Participants: 214
Study Start date:
March 01, 2016
Estimated Completion Date:
March 31, 2021

Connect with a study center

  • Gazi University Medical Faculty

    Ankara, 06560
    Turkey

    Active - Recruiting

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