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

Anemia of Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03521713
• Other study ID #: DAEPO_ANE_III
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2016
• Est. completion date: March 2021

Study information

• Verified date: December 2019
• Source: Dong-A ST Co., Ltd.
• Contact: Ayse Uslu
• Phone: 90 312 284 50 85
• Email: ayse.uslu[@]triogrup-cro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: March 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• EPORON
Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL Formulation : Solution in PFS
• EPREX
Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL Formulation : Solution in PFS

Locations

Country	Name	City	State
Turkey	Gazi University Medical Faculty	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety: Any adverse events	Any adverse events	Week 1 to Week 52
Other	Immunogenicity: Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2~Week 1 (Prior to Dose))	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
Primary	Mean Absolute Change in Hb levels	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).	Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Secondary	Hemoglobin Responder Rate		Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Secondary	Mean EPO dosage (Week 1 to Week 24)		Week 1 ~ Week 24
Secondary	Mean EPO dosage (Week 21 to Week 24)		Week 21 ~ Week 24