New anemia drug for dialysis patients enters final testing phase

NCT ID NCT06466785

Disease control Sponsor: Genexine, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called efepoetin alfa for treating anemia in adults with advanced chronic kidney disease who are on dialysis. About 429 participants will receive either the new drug or an existing one to compare safety and effectiveness. The main goal is to see if the new drug can keep hemoglobin levels stable without needing extra treatments.

Why investors are watching

Genexine is running a Phase III trial of efepoetin alfa, a drug for anemia in kidney disease patients on dialysis, against an active control. For a small company, this late-stage readout is a major event because it tests whether the drug works and is safe in a large group of 429 participants. The result could shape the company's future, since a positive outcome would support a path to market, while a negative one would be a serious setback.

If it works: If the trial shows efepoetin alfa is as effective and safe as the control, Genexine could move closer to seeking approval for a new anemia treatment. That would give the company a product with a clear use in a large patient population on dialysis.

If it fails: Phase III trials often fail, and a negative or unclear result could delay or end the drug's development. For a small company, that could mean losing a key asset and facing a difficult financial position.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 429 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult males and females ≥ 18 years old. 2. 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. 3. 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. 4. 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. 5. Patients must be on stable doses of IV injections of ESA (including biosimilars) for at least 6 weeks prior to Day 1. Minimum ESA dose; * Epoetin alfa, epoetin beta, and epoetin kappa: ≥1,500 U/week * Darbepoetin alfa: ≥20 µg/week * Mircera®: ≥30 µg/2 weeks 6. 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. 7. Patients with serum ferritin ≥100 ng/mL at screening. 8. Patients with transferrin saturation (TSAT) ≥20% at screening. 9. Serum folate concentrations ≥lower limit of normal (LLN) at screening. 10. Serum total vitamin B12 concentrations ≥LLN at screening. Exclusion Criteria: 1. 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). 2. 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. 3. 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. 4. 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 * Total bilirubin \>1.5 x ULN 5. Chronic congestive heart failure (New York Heart Association class III or IV). 6. 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. 7. Uncontrolled hypertension defined as a sitting systolic blood pressure ≥170 mmHg and/or diastolic blood pressure ≥100 mmHg. 8. 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. 9. 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. 10. 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. 11. Any prior functioning organ transplant or a scheduled organ transplantation, or anephric state (one or both kidneys). 12. Planned elective surgery that could lead to significant blood loss during the study period. 13. Hypoalbuminemia (Serum albumin \<2.5 g/dL) at Screening Visit. 14. Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1. 15. Life expectancy of \<12 months. 16. Cognitive or psychiatric condition rendering the patient unable to be cooperative with and complete study requirements. 17. Hypersensitivity to any one of the investigational drugs or its excipients. 18. 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). 19. Immunosuppressive therapy (tacrolimus/cyclosporine, and other than corticosteroids for a chronic condition) within 12 weeks prior to Day 1. 20. History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than \>3 alcoholic beverages per day. 21. Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study. 22. 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. 23. 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. 24. Patients with very limited functional capacity for which a target Hb value of 12 g/dL may have a lower benefit/risk ratio. 25. 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

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Conditions

The condition(s) this trial relates to.

anemia due to chronic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia of chronic kidney disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

42 sites in 7 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

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

Foggia, Italy
"BEST LIFE" Medical Center Armenian-Japanese Joint Venture LLC
RECRUITING

Yerevan, Armenia
'Astghik'' Medical Center
RECRUITING

Yerevan, Armenia
AOU Integrata di Verona UOC Nefrologia
RECRUITING

Verona, Italy
AOU Pisana UO Nefrologia Trapianti e Dialisi
RECRUITING

Pisa, Italy
Acibadem CityClinic UMHAT Tokuda EAD
RECRUITING

Sofia, Bulgaria
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia- Unità Operativa (UO) Nefrologia
RECRUITING

Brescia, Italy
B. Braun Avitum s.r.o - Dialyzacni stredisko Teplice - Nefrologicka ambulance
RECRUITING

Teplice, Czechia
Batumi Dialysis and Nephrology Center
COMPLETED

Batumi, Georgia
Clinic for Nephrology and Dialysis, University Clinical Center Kragujevac
RECRUITING

Kragujevac, Serbia
Clinic for Nephrology and Dialysis, University Clinical Center Nis
RECRUITING

Niš, Serbia
Clinic for Nephrology, Clinical Hospital Center Zvezdara
RECRUITING

Belgrade, Serbia
Clinical Center for Nephrology Development
COMPLETED

Tbilisi, Georgia
DaVita Sp. z o.o. Pszczyna
RECRUITING

Pszczyna, Poland
DaVita Sp. z o.o. Zyrardow
RECRUITING

Żyrardów, Poland
DaVita Stacja Dializ Brodnica
RECRUITING

Brodnica, Poland
DaVita Stacja Dializ WADOWICE
RECRUITING

Wadowice, Poland
DaVita Stacja Dializ Warszawa
RECRUITING

Warsaw, Poland
DaVita sp. z o.o. Warszawa Mangalia
RECRUITING

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

Sliven, Bulgaria
Department of Dialysis Treatment, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich
RECRUITING

Dobrich, Bulgaria
Department of Dialysis Treatment, Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv
RECRUITING

Plovdiv, Bulgaria
Department of Dialysis Treatment, University Multiprofile Hospital for Active Treatment "Medica Ruse" OOD, Ruse
RECRUITING

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

Gabrovo, Bulgaria
Dialysis Center - Dialmed
RECRUITING

Sofia, Bulgaria
Dialysis Center Hemomed EOOD
RECRUITING

Sofia, Bulgaria
Diaslys Center - Pazardzhik
RECRUITING

Pazardzhik, Bulgaria
Ege University Faculty of Medicine Hospital
COMPLETED

Izmir, Turkey (Türkiye)
Erciyes University Faculty of Medicine Hospital
COMPLETED

Kayseri, Turkey (Türkiye)
Far Eastern Memorial Hospital
RECRUITING

New Taipei City, Taiwan
First Dialysis Services Bulgaria EAD, Plovdiv
RECRUITING

Plovdiv, Bulgaria
First Dialysis Services Bulgaria EAD, branck Montana
RECRUITING

Montana, Bulgaria
HDS Privamed Healthia sro v Plzni
RECRUITING

Pilsen, Czechia
Hualien Tzu Chi Hospital
RECRUITING

Hualien City, Taiwan
ICS Maugeri
RECRUITING

Pavia, Italy
IRCCS Ospedale Policlinico San Martino
RECRUITING

Genova, Italy
Kangdong KyungHee University Hospital
COMPLETED

Seoul, South Korea
Kocaeli University Faculty of Medicine Hospital
COMPLETED

Kocaeli, Turkey (Türkiye)
Korea University Ansan Hospital
COMPLETED

Ansan, South Korea
L.Managadze National Center of Urology
COMPLETED

Tbilisi, Georgia
Multiprofile Hospital for Active Treatment Puls AD
RECRUITING

Blagoevgrad, Bulgaria
Multiprofile Hospital for Active Treatment Sveta Anna - Varna AD
RECRUITING

Varna, Bulgaria
Nemocnice Cesky krumlov
RECRUITING

Český Krumlov, Czechia
Nemocnice Havlíčkův Brod
RECRUITING

Havlíčkův Brod, Czechia
RS Islam Jakarta Cempaka Putih
COMPLETED

Jakarta, Indonesia
RSPAD Gatot Soebroto
COMPLETED

Jakarta, Indonesia
RSUP Dr. Hasan Sadikin
COMPLETED

Bandung, Indonesia
RSUPN Dr. Cipto Mangunkusumo
COMPLETED

Jakarta, Indonesia
SODc Nefrologia Dialisi Trapianto Azienda Ospedaliero Universitaria Careggi
RECRUITING

Florence, Italy
Samodzielny Publiczny Zakład Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
RECRUITING

Lodz, Poland
Shuang Ho Hospital
RECRUITING

New Taipei City, Taiwan
St Mary's Incheon Hospital
COMPLETED

Incheon, South Korea
St Mary's Seoul Hospital
COMPLETED

Seoul, South Korea
St Mary's Yeouido Hospital
COMPLETED

Seoul, South Korea
Taipei Medical University Hospital
RECRUITING

Taipei, Taiwan
Tbilisi Heart And Vascular Clinic
COMPLETED

Tbilisi, Georgia
Wojewodzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku
RECRUITING

Bialystok, Poland

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