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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 body's tissues, often leading to fatigue and weakness. Chronic kidney disease is a long-term condition where the kidneys do not work as well as they should. Dialysis is a treatment that takes over the job of the kidneys when they fail. The study will compare the effectiveness and safety of a new medication called efepoetin alfa (also known by the code name GX-E4) with an existing medication called darbepoetin alfa, which is marketed under the name Aranesp. Both medications are solutions for injection and are used to help increase red blood cell production in the body.

The purpose of the study is to evaluate how well efepoetin alfa controls hemoglobin levels compared to darbepoetin alfa in patients undergoing hemodialysis. Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. The study will involve participants receiving either efepoetin alfa or darbepoetin alfa through intravenous injections over a period of up to 52 weeks. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study aims to determine if efepoetin alfa is not inferior to darbepoetin alfa in maintaining stable hemoglobin levels in these patients.

Throughout the study, participants will have their hemoglobin levels monitored regularly to assess the effectiveness of the treatment. The study will also observe any side effects or safety concerns associated with the medications. By the end of the study, researchers hope to gather enough information to understand whether efepoetin alfa is a viable alternative to darbepoetin alfa for treating anemia in patients with chronic kidney disease on dialysis.

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 necessary criteria, including 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.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility and establish baseline health metrics, including hemoglobin levels.

  3. Step 3

    Treatment phase

    The patient will receive either efepoetin alfa or darbepoetin alfa through intravenous injection. The specific medication and dosage will be determined by the study protocol.

    The treatment aims to manage anemia by maintaining hemoglobin levels within a target range.

  4. Step 4

    Monitoring and evaluation

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

    Adjustments to the treatment may be made based on these evaluations to ensure optimal hemoglobin control.

  5. Step 5

    Evaluation period

    From Week 20 to Week 28, the patient's hemoglobin levels will be closely monitored to evaluate the mean change from baseline.

    The study will assess the proportion of patients maintaining hemoglobin levels within the target range during this period.

  6. Step 6

    Maintenance period

    Following the evaluation period, the patient will continue treatment during a maintenance phase, with ongoing monitoring of hemoglobin levels.

    The study will continue to assess the effectiveness of the treatment in maintaining stable hemoglobin levels.

  7. Step 7

    Completion of study

    Upon completion of the study, the patient's overall response to the treatment will be evaluated.

    The study aims to determine the efficacy and safety of efepoetin alfa compared to darbepoetin alfa in managing anemia in patients with chronic kidney disease on dialysis.

Who can join the trial?

10 criteria

  • Adults 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 during screening.
  • Have signed a consent form after understanding the study and having the chance to ask questions.
  • Have **stage 5 chronic kidney disease (CKD)**, which means the kidneys are not working well, and are on **hemodialysis** (a treatment to clean the blood) for at least 12 weeks before the study starts.
  • Have a **single-pool Kt/V** of 1.2 or higher, or a **urea reduction ratio** of 65% or higher, which are measures of how well dialysis is working, based on tests done within 4 weeks before screening or during screening.
  • Have been receiving stable doses of **erythropoiesis stimulating agents (ESA)**, which are medicines that help the body make red blood cells, for at least 6 weeks before the study starts. The **hemoglobin (Hb)** levels should be between 9.0 and 12.0 grams per deciliter.
  • The average of the two most recent hemoglobin tests, done at least 6 days apart, should be between 9.0 and 12.0 grams per deciliter, with a difference of no more than 1.5 grams per deciliter between the highest and lowest values.
  • Have a **serum ferritin** level of 100 nanograms per milliliter or higher during screening. Ferritin is a protein that stores iron in the body.
  • Have a **transferrin saturation (TSAT)** of 20% or higher during screening. 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 during screening. Folate is a type of vitamin B that is 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 caused by chronic kidney disease cannot participate.
  • Patients who are not receiving hemodialysis 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 have participated in another clinical trial recently cannot participate.
  • Patients who have allergies to the study medications cannot participate.
  • Patients who have a history of certain blood disorders 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 production of 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 by helping the body produce more red blood cells, thereby increasing hemoglobin levels.

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, ensuring they remain stable. Efepoetin Alfa works by stimulating the bone marrow to produce more red blood cells, which is crucial for patients with anemia. It is classified as an erythropoiesis-stimulating agent, a type of medication that encourages the production of red blood cells.

  • Darbepoetin Alfa

    This medication is also administered through injection and is used to treat anemia, particularly in patients with chronic kidney disease undergoing dialysis. It is well-established in medical practice and literature for its role in managing hemoglobin levels. Darbepoetin Alfa functions by stimulating the bone marrow to increase red blood cell production, similar to the natural hormone erythropoietin. It belongs to the class of erythropoiesis-stimulating agents, which are used to boost red blood cell production in the body.

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, impacting overall health and energy levels. The progression of anemia in these patients is closely monitored to manage symptoms and maintain quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503634-50-01Protocol codeGX-E4-CKD-002Estimated enrolment544 patientsSponsorGenexine Inc.

sourced from the EU Clinical Trials Register and site verification

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