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Anemia of Chronic Kidney DiseasePhase 3NCT06466785

A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

A Phase 3 study testing Efepoetin Alfa and Darbepoetin Alfa in people with Anemia of Chronic Kidney Disease, run by Genexine, Inc. at 58 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

An investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia of Chronic Kidney Disease
What is being tested?
Efepoetin Alfa and Darbepoetin Alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
429 participants
Where
58 sitesin 11 countries
Study dates
25 Jan 2024to Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult males and females ≥ 18 years old.
  • Patient (or patient's legally acceptable representative) has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC) or institutional review board (IRB), after the nature of the study has been explained and the patient has had the opportunity to ask questions.
  • Patient with stage 5 CKD defined by estimated GFR (eGFR, ≤15 mL/min/1.73m2) on adequate HD for a minimum of 12 weeks prior to Day 1. *CKD staging will be based on the five-stage system for classification of CKD based on KDIGO guidelines.
  • Hemodialysis patients with single-pool Kt/V ≥ 1.2 or urea reduction ratio ≥ 65%.
  • Single-pool Kt/V or urea reduction ratio will be based on results measured within 4 weeks prior to screening or during the screening period.
  • Patients must be on stable doses of IV injections of ESA (including biosimilars) for at least 6 weeks prior to Day 1.
Show all 15Show fewer
  • Minimum ESA dose;
  • Epoetin alfa, epoetin beta, and epoetin kappa: ≥1,500 U/week
  • Darbepoetin alfa: ≥20 µg/week
  • Mircera®: ≥30 µg/2 weeks
  • Mean of the 2 most recent local laboratory Hb screening values obtained at least 6 days apart, must be 9.0 g/dL to 12.0 g/dL, inclusive, with a difference of ≤1.5 g/dL between the highest and the lowest value.
  • Patients with serum ferritin ≥100 ng/mL at screening.
  • Patients with transferrin saturation (TSAT) ≥20% at screening.
  • Serum folate concentrations ≥lower limit of normal (LLN) at screening.
  • Serum total vitamin B12 concentrations ≥LLN at screening.

Who cannot join

  • Active acute or chronic infection, or uncontrolled or symptomatic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease), or a C reactive protein level 40> mg/L (high sensitive C-reactive protein level > 10 mg/L).
  • By history or current clinical evidence, patients with active acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection should be excluded. Routine screening for HBV, HCV, and human immunodeficiency virus (HIV) infection is not required in this protocol. Chronic HBV/HCV infection with liver function tests (LFT) >3 times of normal are excluded. Known HIV positive patients are excluded.
  • History or clinical evidence of cardiovascular, hematologic, hepatic, or any physical conditions that, in the opinion of the Investigator, would compromise participation in the study.
  • Any of the following laboratory abnormalities at screening visit;
  • Alanine transaminase (ALT) >3 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) >3 x ULN
Show all 28Show fewer
  • Total bilirubin >1.5 x ULN
  • Chronic congestive heart failure (New York Heart Association class III or IV).
  • High risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before Screening or during Screening.
  • Uncontrolled hypertension defined as a sitting systolic blood pressure ≥170 mmHg and/or diastolic blood pressure ≥100 mmHg.
  • History of active malignancy except for cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site.
  • Patients with a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥1 g/dL within the last 8 weeks prior to Screening.
  • Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.
  • Any prior functioning organ transplant or a scheduled organ transplantation, or anephric state (one or both kidneys).
  • Planned elective surgery that could lead to significant blood loss during the study period.
  • Hypoalbuminemia (Serum albumin <2.5 g/dL) at Screening Visit.
  • Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1.
  • Life expectancy of <12 months.
  • Cognitive or psychiatric condition rendering the patient unable to be cooperative with and complete study requirements.
  • Hypersensitivity to any one of the investigational drugs or its excipients.
  • Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to Screening, or blood transfusion is anticipated during the study period (excluding temporary blood transfusion given in case of blood loss due to accident or surgery).
  • Immunosuppressive therapy (tacrolimus/cyclosporine, and other than corticosteroids for a chronic condition) within 12 weeks prior to Day 1.
  • History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than >3 alcoholic beverages per day.
  • Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study.
  • Females of childbearing potential or males who are unable/unwilling to take adequate contraceptive precautions defined by the protocol for the duration of the study and for at least 4 months for male subjects and 7 months for female patients after the end of the study. Females with a positive pregnancy test result within 24 hours prior to study entry, are otherwise known to be pregnant, plan to become pregnant in the next 12 months or are currently breastfeeding.
  • Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Sponsor or clinical research organization (CRO) employees directly involved in the conduct of the study.
  • Patients with very limited functional capacity for which a target Hb value of 12 g/dL may have a lower benefit/risk ratio.
  • Any medical condition (patients weighing over 150 kg) that, in the opinion of the Investigator, may pose a safety risk to a patient in this study, may confound efficacy or safety assessment, or may interfere with study participation

Trial locations and contacts

58 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Yoon-Jeong Choi contact

+82-2-6098-2756

yoonjeong.choi@genexine.com

TaeKyung Seong contact

+82-2-6098-2759

taekyung.seong@genexine.com

58 sites in 11 countries

Bulgaria13 sites, 13 recruiting

  • Multiprofile Hospital for Active Treatment Puls AD

    Blagoevgrad

    Tanya Yanakieva, MD

    Recruiting

  • Department of Dialysis Treatment, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich

    Dobrich

    Svetla Dimitrova, MD

    Recruiting

  • Department of Nephrology, Dialysis Treatment, Multiprofile Hospital for Active Treatment "Dr. Tota Venkova" AD, Gabrovo

    Gabrovo

    Boyan Kirov, MD

    Recruiting

  • First Dialysis Services Bulgaria EAD, branck Montana

    Montana

    Irena Asenova Dimitrova, MD

    Recruiting

  • Diaslys Center - Pazardzhik

    Pazardzhik

    Tsvetelina Chardakova, MD

    Recruiting

  • Department of Dialysis Treatment, Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv

    Plovdiv

    Pavlina Slavcheva Paunova, MD

    Recruiting

  • First Dialysis Services Bulgaria EAD, Plovdiv

    Plovdiv

    Tanya Kostadinova, MD

    Recruiting

  • Department of Dialysis Treatment, University Multiprofile Hospital for Active Treatment "Medica Ruse" OOD, Ruse

    Rousse

    Boyan Petkov, MD

    Recruiting

  • Department of Dialysis Treatment, Multiprofile Hospital for Active Treatment "Dr. Ivan Selimski - Sliven" AD, Sliven

    Sliven

    Maria Nikolova, MD

    Recruiting

  • Acibadem CityClinic UMHAT Tokuda EAD

    Sofia

    Aleksandar Osichenko, MD

    Recruiting

  • Dialysis Center - Dialmed

    Sofia

    Ivaylo Sredkov, MD

    Recruiting

  • Dialysis Center Hemomed EOOD

    Sofia

    Nencho Nenchev, MD

    Recruiting

  • Multiprofile Hospital for Active Treatment Sveta Anna - Varna AD

    Varna

    Milev Radostin, MD

    Recruiting

Other trials in Bulgaria

Poland8 sites, 8 recruiting

  • Wojewodzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku

    Bialystok

    Tomasz Hryszko, MD

    Recruiting

  • DaVita Stacja Dializ Brodnica

    Brodnica

    Liliana Chodara-Kuc, MD

    Recruiting

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

    Lodz

    Michal Nowicki, MD

    Recruiting

  • DaVita Sp. z o.o. Pszczyna

    Pszczyna

    Maciej Drozdz, MD

    Recruiting

  • DaVita Stacja Dializ WADOWICE

    Wadowice

    Piotr Jaskowski, MD

    Recruiting

  • DaVita sp. z o.o. Warszawa Mangalia

    Warsaw

    Marta Serwańska-Świętek, MD

    Recruiting

  • DaVita Stacja Dializ Warszawa

    Warsaw

    Anna Popow, MD

    Recruiting

  • DaVita Sp. z o.o. Zyrardow

    Żyrardów

    Krzysztof Wroblewski, MD

    Recruiting

Other trials in Poland

Italy7 sites, 7 recruiting

  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia- Unità Operativa (UO) Nefrologia

    Brescia

    Federico Alberici, MD

    Recruiting

  • SODc Nefrologia Dialisi Trapianto Azienda Ospedaliero Universitaria Careggi

    Florence

    Calogero Lino Cirami, MD

    Recruiting

  • "Azienda Ospedaliero Universitaria ""Ospedali Riuniti"" di Foggia Unità Operativa Complessa di Nefrologia, Dialisi e Trapianto"

    Foggia

    Giovanni Stallone, MD

    Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova

    Francesca Viazzi, MD

    Recruiting

  • ICS Maugeri

    Pavia

    Ciro Esposito

    Recruiting

  • AOU Pisana UO Nefrologia Trapianti e Dialisi

    Pisa

    Vincenzo Panichi, MD

    Recruiting

  • AOU Integrata di Verona UOC Nefrologia

    Verona

    Giovanni Gambaro, MD

    Recruiting

Other trials in Italy

South Korea5 sites

  • Korea University Ansan Hospital

    Ansan

    Completed

  • St Mary's Incheon Hospital

    Incheon

    Completed

  • Kangdong KyungHee University Hospital

    Seoul

    Completed

  • St Mary's Seoul Hospital

    Seoul

    Completed

  • St Mary's Yeouido Hospital

    Seoul

    Completed

Other trials in South Korea

Czechia4 sites, 4 recruiting

  • Nemocnice Cesky krumlov

    Český Krumlov

    Richard Kovář, MD

    Recruiting

  • Nemocnice Havlíčkův Brod

    Havlíčkův Brod

    Frantisek Senk, MD

    Recruiting

  • HDS Privamed Healthia sro v Plzni

    Pilsen

    MUDr. Jan Wirth, MD

    Recruiting

  • B. Braun Avitum s.r.o - Dialyzacni stredisko Teplice - Nefrologicka ambulance

    Teplice

    Dr Frantisek Svara, MD

    Recruiting

Other trials in Czechia

Georgia4 sites

  • Batumi Dialysis and Nephrology Center

    Batumi

    Completed

  • Clinical Center for Nephrology Development

    Tbilisi

    Completed

  • L.Managadze National Center of Urology

    Tbilisi

    Completed

  • Tbilisi Heart And Vascular Clinic

    Tbilisi

    Completed

Other trials in Georgia

Indonesia4 sites

  • RSUP Dr. Hasan Sadikin

    Bandung

    Completed

  • RS Islam Jakarta Cempaka Putih

    Jakarta

    Completed

  • RSPAD Gatot Soebroto

    Jakarta

    Completed

  • RSUPN Dr. Cipto Mangunkusumo

    Jakarta

    Completed

Other trials in Indonesia

Taiwan4 sites, 4 recruiting

  • Hualien Tzu Chi Hospital

    Hualien City

    Bang-Gee Hsu, MD

    Recruiting

  • Far Eastern Memorial Hospital

    New Taipei City

    Yu-Sen Peng, MD

    Recruiting

  • Shuang Ho Hospital

    New Taipei City

    I-Wen Wu, MD

    Recruiting

  • Taipei Medical University Hospital

    Taipei

    I-Wen Wu, MD

    Recruiting

Other trials in Taiwan

Armenia3 sites, 3 recruiting

  • "ARABKIR" Joint Medical Center & Institute of Child and Adolescent Health

    Yerevan

    Helen Nazaryan, MD

    Recruiting

  • "BEST LIFE" Medical Center Armenian-Japanese Joint Venture LLC

    Yerevan

    Arkadi Chakhoyan, MD

    Recruiting

  • 'Astghik'' Medical Center

    Yerevan

    Artur Safaryan, MD

    Recruiting

Other trials in Armenia

Serbia3 sites, 3 recruiting

  • Clinic for Nephrology, Clinical Hospital Center Zvezdara

    Belgrade

    Snezana Pesic, MD

    Recruiting

  • Clinic for Nephrology and Dialysis, University Clinical Center Kragujevac

    Kragujevac

    Tomislav Nikolic, MD

    Recruiting

  • Clinic for Nephrology and Dialysis, University Clinical Center Nis

    Niš

    Branka Mitic, MD

    Recruiting

Other trials in Serbia

Turkey (Türkiye)3 sites

  • Ege University Faculty of Medicine Hospital

    Izmir

    Completed

  • Erciyes University Faculty of Medicine Hospital

    Kayseri

    Completed

  • Kocaeli University Faculty of Medicine Hospital

    Kocaeli

    Completed

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase III, Randomized, Investigator-Blinded, Active-Controlled Study of Efficacy and Safety of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

An investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis

Read the detailed description

This is an investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis. Eligible patients will be randomized to efepoetin alfa or darbepoetin alfa at a ratio of 2:1. An unblinded team will prepare and administer the study drug at the dosages decided by the blinded Investigator.

The study consists of 3 study periods:

  • Screening (up to 28 days before Day 1): subjects in screening will continue treatment with epoetin, methoxy polyethylene glycol-epoetin beta, or darbepoetin alfa as per local standard of care.
  • Treatment: subjects will discontinue any prior erythropoietin analogue and will be randomized to switch to efepoetin alfa or darbepoetin alfa in a 2:1 ratio.

The aim of the treatment period is to maintain Hb levels between 10.0 g/dL and 12.0 g/dL. It is recommended that study treatment be administered any time after completion of dialysis if dosing is scheduled on a dialysis day to avoid potential bias on study assessments.

  • Follow-up (4 weeks) Phone contacts can be done for follow-up for up to Week 56 or at the time of the last patient's Week 56 visit, whichever is shorter.
Being tested
Efepoetin Alfa, Darbepoetin Alfa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efepoetin AlfaDrug

    Also called GX-E4

    Efepoetin alfa (Epoetin-Fc fusion protein, GX-E2 or GX-E4,) is a novel long-acting erythropoietin-hybrid fragment crystallizable (Fc) fusion protein developed by Genexine, intended for treatment and maintenance of anemia due to CKD with or without dialysis. Its drug substance is a recombinant form of human EPO and hybrid Fc (hyFc®) fragment consisting of 2 subunits with a total of 411 amino acid residues. Each subunit contains an EPO molecule linked to a hybrid Fc fragment of c terminal of CH2 and CH3 regions from IgG4 and to N-terminal of CH2 region and the hinge sequence from IgD. These 2 subunits are joined by a single disulfide bond at the hinge region of each subunit. Half-life is 138.5-157.9 hours. It is an acidic glycoprotein of about 30 kDa and comprises 165 amino acids and 4 glycans. Circulating EPO exhibits several glycosylation isoforms that differ in electrical charge and biological activity

  • Darbepoetin AlfaDrug

    Also called Aranesp®

    Darbepoetin alfa is a re-engineered form of erythropoietin containing 5 amino acid changes (N30, T32, V87, N88, T90) resulting in the creation of 2 new sites for N-linked carbohydrate addition. It has a 3-fold longer serum half-life compared to epoetin alpha and epoetin beta. It stimulates erythropoiesis (increases red blood cell levels) by the same mechanism as rHuEpo (binding and activating the Epo receptor) and is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy

Study groups in NCT06466785
Study groupRoleWhat they receive
Efepoetin Alfa (GX-E4)ExperimentalDose: 0.3 mg/0.3 mL, 0.6 mg/0.6 mL and 1 mg/1 mL pre-filled syringe (PFS) solution. The dose of study drug can be varied depending on the level of Hb. Frequency: Efepoetin alfa should be administered at 1-week intervals from Day 1 (Visit 2) to Week 28 (Visit 30), but the administration interval may be changed to 1 or 2 weeks from Week 29 (Visit 31) to Week 52 (Visit 54) according to the investigator's judgement. Mode of administration: intravenous injection. When the dose of investigational product (IP) is planned on the same day as hemodialysis (HD), the IP should be injected at the end of HD.
Receives: Drug: Efepoetin Alfa
Darbepoetin Alfa (Aranesp®)Active comparatorDose: 20 µg/0.5 mL, 30 µg/0.3 mL, 60 µg/0.3 mL, 100 μg/0.5 mL PFS. The dose of comparator drug can be varied depending on the level of Hb. Frequency: Darbepoetin alfa should be administered at 1-week intervals from Day 1 (Visit 2) to Week 28 (Visit 30), but the administration interval may be changed to 1 or 2 weeks from Week 29 (Visit 31) to Week 52 (Visit 54) according to the investigator's judgement. Mode of administration: intravenous injection.
Receives: Drug: Darbepoetin Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in hemoglobin (Hb)

    Mean change from Baseline in Hb averaged over Week 20 to Week 28 without the use of rescue therapy (i.e., transfusion, or any approved ESA for all patients) within 6 weeks prior to and during the 8-week evaluation period.

    Measured: Over Week 20 to Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2024
  2. Study start25 Jan 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
429 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06466785
Sponsor's protocol ID
GX-E4-CKD-002
Status last verified
May 2026
First submitted
14 Jun 2024
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Efepoetin Alfa and Darbepoetin Alfa in people with Anemia of Chronic Kidney Disease, run by Genexine, Inc. at 58 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in Bulgaria, Poland, Italy, South Korea, Czechia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yoon-Jeong Choi (+82-2-6098-2756, yoonjeong.choi@genexine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in hemoglobin (Hb) (time frame: Over Week 20 to Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06466785.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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