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

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.

Study Overview

• Status: Unknown
• Conditions: Anemia of Chronic Kidney Disease
• Intervention / Treatment: Drug: EPORON; Drug: EPREX

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Recruiting
    • Gazi University Medical Faculty
    • Contact: Turgay Arinsoy, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Erythropoietin Alpha
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: Erythropoietin Alpha

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Safety: Any adverse events	Any adverse events	Week 1 to Week 52
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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Study Chair: Turgay Arinsoy, MD, Gazi University Medical Faculty

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: April 29, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: DAEPO_ANE_III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No