NCT03521713

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia of Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	EPORON	* Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL * Formulation : Solution in PFS
DRUG	EPREX	* Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL * Formulation : Solution in PFS

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-09-01
• Completion: 2021-03-01
• First posted: 2018-05-11
• Last updated: 2019-12-10

Locations

1 site across 1 country: Turkey (Türkiye)