Back to resultsTo Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)
Primary Purpose
Anemia of Chronic Kidney Disease
Status
Unknown status
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
EPORON
EPREX
Sponsored by
About this trial
This is an interventional treatment trial for Anemia of Chronic Kidney Disease
Eligibility Criteria
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
Sites / Locations
- Gazi University Medical FacultyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EPORON
EPREX
Arm Description
<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.
<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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Hemoglobin Responder Rate
Mean EPO dosage (Week 1 to Week 24)
Mean EPO dosage (Week 21 to Week 24)
Full Information
NCT ID
NCT03521713
First Posted
February 21, 2017
Last Updated
December 9, 2019
Sponsor
Dong-A ST Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03521713
Brief Title
To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Only investigators will be blinded
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EPORON
Arm Type
Experimental
Arm Description
<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.
Arm Title
EPREX
Arm Type
Active Comparator
Arm Description
<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.
Intervention Type
Drug
Intervention Name(s)
EPORON
Other Intervention Name(s)
Erythropoietin Alpha
Intervention Description
Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL
Formulation : Solution in PFS
Intervention Type
Drug
Intervention Name(s)
EPREX
Other Intervention Name(s)
Erythropoietin Alpha
Intervention Description
Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL
Formulation : Solution in PFS
Primary Outcome Measure Information:
Title
Mean Absolute Change in Hb levels
Description
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).
Time Frame
Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Secondary Outcome Measure Information:
Title
Hemoglobin Responder Rate
Time Frame
Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Title
Mean EPO dosage (Week 1 to Week 24)
Time Frame
Week 1 ~ Week 24
Title
Mean EPO dosage (Week 21 to Week 24)
Time Frame
Week 21 ~ Week 24
Other Pre-specified Outcome Measures:
Title
Safety: Any adverse events
Description
Any adverse events
Time Frame
Week 1 to Week 52
Title
Immunogenicity: Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2~Week 1 (Prior to Dose))
Description
Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2~Week 1 (Prior to Dose))
Time Frame
(Week -2~Week 1 (Prior to Dose)), Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayse Uslu
Phone
90 312 284 50 85
Email
ayse.uslu@triogrup-cro.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turgay Arinsoy, MD
Organizational Affiliation
Gazi University Medical Faculty
Official's Role
Study Chair
Facility Information:
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Turgay Arinsoy, M.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)
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