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

NCT03521713 | Unknown Phase 3

• 1 other identifier: DAEPO_ANE_III
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Outcomes (2)

• Safety: 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))

  (Week -2~Week 1 (Prior to Dose)), Week 52

Study Arms (2)

EPORON

EXPERIMENTAL

\<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

EPREX

ACTIVE COMPARATOR

\<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

Interventions

EPORON DRUG

* Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL * Formulation : Solution in PFS

Also known as: Erythropoietin Alpha

EPORON

EPREX DRUG

* Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL * Formulation : Solution in PFS

Also known as: Erythropoietin Alpha

EPREX

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Gazi University Medical Faculty

Ankara, 06560, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Epoetin Alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Turgay Arinsoy, MD

  Gazi University Medical Faculty

  STUDY CHAIR

Central Study Contacts

Ayse Uslu

CONTACT

90 312 284 50 85; ayse.uslu@triogrup-cro.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Only investigators will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: May 11, 2018
• Study Start: March 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: March 1, 2021
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)