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Study on Efepoetin Alfa and Darbepoetin Alfa for Treating Anemia in Patients with Chronic Kidney Disease on Dialysis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of anemia in patients with chronic kidney disease who are on dialysis. Anemia is a condition where the body does not have enough healthy red blood cells to carry adequate oxygen to the tissues, which can make a person feel tired and weak. Chronic kidney disease is a long-term condition where the kidneys do not work as well as they should. The study will compare the effectiveness and safety of a new treatment called efepoetin alfa (also known by the code name GX-E4) with an existing treatment called darbepoetin alfa, which is marketed under the name Aranesp.

The purpose of the study is to evaluate how well efepoetin alfa controls hemoglobin levels in patients. Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. The study will involve patients receiving either efepoetin alfa or darbepoetin alfa through intravenous injections. The study will last for a period of 52 weeks, during which the patients' hemoglobin levels will be monitored to see if efepoetin alfa is as effective as darbepoetin alfa in maintaining these levels.

Participants in the study will receive regular injections and have their health closely monitored by healthcare professionals. The study aims to provide valuable information on whether efepoetin alfa can be a safe and effective alternative to current treatments for anemia in patients with chronic kidney disease on dialysis. This research could potentially lead to improved treatment options for managing anemia in these patients.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will have already met the inclusion criteria, such as being an adult with chronic kidney disease on dialysis and having stable hemoglobin levels.

    The patient will have signed an informed consent form, indicating understanding of the study's nature and procedures.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to establish baseline health metrics, including hemoglobin levels and other relevant blood tests.

    This assessment will help determine the starting point for evaluating the effectiveness of the treatment.

  3. Step 3

    Treatment phase

    The patient will receive efepoetin alfa or darbepoetin alfa as part of the treatment for anemia.

    The medications will be administered as a solution for injection through an intravenous route.

    The specific products used include GX-E4 and Aranesp in varying dosages: 20, 30, 60, and 100 micrograms, depending on the patient's needs.

  4. Step 4

    Monitoring and evaluation

    The patient's hemoglobin levels will be monitored regularly to assess the effectiveness of the treatment.

    The primary goal is to maintain hemoglobin levels between 10.0 and 12.0 g/dL over a specified period, typically from Week 20 to Week 28.

  5. Step 5

    Adjustments and rescue therapy

    If necessary, adjustments to the treatment may be made based on the patient's response.

    Rescue therapy, such as blood transfusions or other approved treatments, may be provided if hemoglobin levels fall below the desired range.

  6. Step 6

    Quality of life assessment

    Throughout the study, the patient's quality of life will be assessed using a standardized questionnaire.

    This assessment will help determine the impact of the treatment on the patient's overall well-being.

  7. Step 7

    Completion of the study

    Upon completion of the study, the patient's final health metrics will be recorded.

    The data collected will contribute to evaluating the efficacy and safety of efepoetin alfa compared to darbepoetin alfa.

Who can join the trial?

10 criteria

  • Adults, both men and women, who are **18 years old** or older.
  • Have a **vitamin B12** level in the blood that is at or above the lower limit of normal when tested.
  • Have signed a consent form, or have a representative sign it, after understanding the study and having the chance to ask questions.
  • Have **chronic kidney disease (CKD)** at stage 4 or 5, which means the kidneys are not working well, with a specific measure called **estimated GFR** being 29 or less. They must have been on **hemodialysis** (a treatment to clean the blood) for at least 12 weeks before starting the study.
  • Have a **hemodialysis** efficiency measure called **single-pool Kt/V** of 1.2 or more, or a **urea reduction ratio** of 65% or more.
  • Have been receiving stable doses of **ESA** (a type of medication given by injection) for at least 6 weeks before starting the study. The minimum doses are: 1,500 units per week for certain types of ESA, 20 micrograms per week for **darbepoetin alfa**, and 30 micrograms every 2 weeks for **Mircera®**.
  • Have two recent **hemoglobin (Hb)** blood test results, taken at least 6 days apart, showing levels between 9.0 and 12.0, with no more than a 1.5 difference between the highest and lowest values.
  • Have a **serum ferritin** level of 100 or more when tested. **Ferritin** is a protein that stores iron in the body.
  • Have a **transferrin saturation (TSAT)** of 20% or more when tested. **TSAT** is a measure of how much iron is available in the blood.
  • Have a **serum folate** level at or above the lower limit of normal when tested. **Folate** is a type of vitamin B important for making red blood cells.

Who cannot join the trial?

10 criteria

  • Patients who are not on dialysis cannot participate.
  • Patients who do not have anemia due to chronic kidney disease cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not able to follow the study procedures cannot participate.
  • Patients who have any other medical condition that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients who have had a recent blood transfusion cannot participate.
  • Patients who have a history of allergic reactions to similar medications cannot participate.
  • Patients who have uncontrolled high blood pressure cannot participate.
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Investigated drugs

  • Efepoetin Alfa

    is a medication being studied for its ability to treat anemia in patients with chronic kidney disease who are on dialysis. It works by stimulating the bone marrow to produce more red blood cells, which can help increase hemoglobin levels and improve symptoms of anemia.

  • Darbepoetin Alfa

    is another medication used in the study as a comparison to efepoetin alfa. It is also used to treat anemia in patients with chronic kidney disease on dialysis. Like efepoetin alfa, it helps the body produce more red blood cells to manage anemia.

What is already known about the treatment

Efepoetin Alfa – This medication is administered via injection and is currently being studied in clinical trials for its effectiveness in treating anemia in patients with chronic kidney disease who are on dialysis. It is designed to help manage hemoglobin levels, aiming to be as effective as another medication called darbepoetin alfa. Efepoetin alfa works by stimulating the bone marrow to produce more red blood cells, which is crucial for patients with anemia. It belongs to a class of drugs known as erythropoiesis-stimulating agents.

Investigated diseases

Anemia in patients with chronic kidney disease on dialysis – This condition occurs when the kidneys, which are responsible for producing a hormone that helps create red blood cells, are damaged and unable to function properly. As a result, the body produces fewer red blood cells, leading to anemia. Patients on dialysis often experience this type of anemia because their kidneys are not able to produce enough erythropoietin, a hormone that stimulates red blood cell production. The anemia can cause symptoms such as fatigue, weakness, and shortness of breath. Over time, the lack of red blood cells can affect the delivery of oxygen to the body's tissues. This condition is commonly managed in patients undergoing dialysis for chronic kidney disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503634-50-00Protocol codeGX-E4-CKD-002Estimated enrolment429 patientsSponsorGenexine Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).