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

NCT03521713 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2019-12-10

No results posted yet for this 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.

Conditions

  • Anemia of Chronic Kidney Disease

Interventions

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

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Turgay Arinsoy, MD · Gazi University Medical Faculty

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2020-09-30
Completion
2021-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03521713 on ClinicalTrials.gov