UnknownPhase 3

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

Turkey (Türkiye)214 participantsStarted 2016-03-01

Plain-language 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.

Who can participate

Age range

19 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Absolute Change in Hb levels

Timeframe: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24

Trial details

NCT IDNCT03521713

SponsorDong-A ST Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-09

Contact for this trial

Ayse Uslu

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

View on ClinicalTrials.gov More Anemia of Chronic Kidney Disease trials

Who can participate

Age range

19 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.