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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 study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria

Other Sites

Site Name City Country Status
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Davita Sp. z o.o. Warsaw Poland
Davita Sp. z o.o. Tomaszow Mazowiecki Poland
Nemocnice Cesky Krumlov a.s. Horni Brana Czechia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Universita’ Degli Studi Di Verona Verona Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Universita Degli Studi Di Brescia Brescia Italy
DaVita Sp.z o.o. – SD Pszczyna Pszczyna Poland
Multiprofile Hospital For Active Treatment St. Anna-Varna AD Varna Bulgaria
Dfrmlnpn Cjadhg Hycwhih Eruv Sofia Bulgaria
Faucv Dwgvvwyl Stullmcw Behynbkc Ely Plovdiv Bulgaria
Fmkmz Dwonyscq Smbkuyhb Bkuhgoer Ege Montana Bulgaria
Nyustovzd vf Fwuwfrzlcktmo ppcolhclxnx ogeosozngo Frydek-Mistek Czechia
Mioucbhfnrg Btvzuj athf Beroun-Mesto Czechia
Dihiun Spc z oipq Miechow Poland
Ukdshpzlisg Mlqwoeeo W Ljouj Lodz Poland
Dycrml Sek z oshr Naklo Nad Notecia Poland
Nqzcann Dvbsuzpy Kmzilze – Mlefyyix Nhrdpwtqlla Kkawckb Miskolc Hungary
Nothvhr Dpuxamkj Kgbvvec Kgoekdfiq Kecskemet Hungary
Anmndeh Oesxhviuvxb Ualngeffumlpp Opozyelv Rfjsyvk Foggia Italy
Dfkcbz Son zaowck Żrognrwg Zyrardow Poland
Phppjbzc Hcjdvupm svojnx Plzen Czechia
Dkjrfj Szx z ofcy Olesnica Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
05.02.2024
Czechia Czechia
Not yet recruiting
05.02.2024
Hungary Hungary
Not yet recruiting
05.02.2024
Italy Italy
Not yet recruiting
05.02.2024
Poland Poland
Not yet recruiting
05.02.2024

Trial locations

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.

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 ID:
2023-503634-50-00
Protocol code:
GX-E4-CKD-002
Trial Phase:
Therapeutic confirmatory (Phase III)

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