RecruitingPhase 3NCT06466785

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

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

Sponsor

Genexine, Inc.

Enrollment

429 participants

Start Date

Jan 25, 2024

Study Type

INTERVENTIONAL

Conditions

Anemia of Chronic Kidney Disease

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This phase III study is testing efepoetin alfa — a drug that stimulates the body to produce more red blood cells — in people with end-stage kidney disease who are on dialysis and have anemia (low red blood cell levels). **You may be eligible if...** - You are 18 or older - You have stage 5 chronic kidney disease (very low kidney function) and have been on dialysis for at least 12 weeks - You have anemia related to your kidney disease **You may NOT be eligible if...** - You have been on dialysis for less than 12 weeks - You have uncontrolled high blood pressure or active cancer - You have had a recent heart attack, stroke, or blood clot Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEfepoetin Alfa

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

DRUGDarbepoetin Alfa

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

Locations(58)

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

Yerevan, Armenia

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

Yerevan, Armenia

'Astghik'' Medical Center

Yerevan, Armenia

Multiprofile Hospital for Active Treatment Puls AD

Blagoevgrad, Bulgaria

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

Dobrich, Bulgaria

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

Gabrovo, Bulgaria

First Dialysis Services Bulgaria EAD, branck Montana

Montana, Bulgaria

Diaslys Center - Pazardzhik

Pazardzhik, Bulgaria

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

Plovdiv, Bulgaria

First Dialysis Services Bulgaria EAD, Plovdiv

Plovdiv, Bulgaria

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

Rousse, Bulgaria

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

Sliven, Bulgaria

Acibadem CityClinic UMHAT Tokuda EAD

Sofia, Bulgaria

Dialysis Center - Dialmed

Sofia, Bulgaria

Dialysis Center Hemomed EOOD

Sofia, Bulgaria

Multiprofile Hospital for Active Treatment Sveta Anna - Varna AD

Varna, Bulgaria

Nemocnice Cesky krumlov

Český Krumlov, Czechia

Nemocnice Havlíčkův Brod

Havlíčkův Brod, Czechia

HDS Privamed Healthia sro v Plzni

Pilsen, Czechia

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

Teplice, Czechia

Batumi Dialysis and Nephrology Center

Batumi, Georgia

Clinical Center for Nephrology Development

Tbilisi, Georgia

L.Managadze National Center of Urology

Tbilisi, Georgia

Tbilisi Heart And Vascular Clinic

Tbilisi, Georgia

RSUP Dr. Hasan Sadikin

Bandung, Indonesia

RS Islam Jakarta Cempaka Putih

Jakarta, Indonesia

RSPAD Gatot Soebroto

Jakarta, Indonesia

RSUPN Dr. Cipto Mangunkusumo

Jakarta, Indonesia

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

Brescia, Italy

SODc Nefrologia Dialisi Trapianto Azienda Ospedaliero Universitaria Careggi

Florence, Italy

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

Foggia, Italy

IRCCS Ospedale Policlinico San Martino

Genova, Italy

ICS Maugeri

Pavia, Italy

AOU Pisana UO Nefrologia Trapianti e Dialisi

Pisa, Italy

AOU Integrata di Verona UOC Nefrologia

Verona, Italy

Wojewodzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku

Bialystok, Poland

DaVita Stacja Dializ Brodnica

Brodnica, Poland

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

Lodz, Poland

DaVita Sp. z o.o. Pszczyna

Pszczyna, Poland

DaVita Stacja Dializ WADOWICE

Wadowice, Poland

DaVita sp. z o.o. Warszawa Mangalia

Warsaw, Poland

DaVita Stacja Dializ Warszawa

Warsaw, Poland

DaVita Sp. z o.o. Zyrardow

Żyrardów, Poland

Clinic for Nephrology, Clinical Hospital Center Zvezdara

Belgrade, Serbia

Clinic for Nephrology and Dialysis, University Clinical Center Kragujevac

Kragujevac, Serbia

Clinic for Nephrology and Dialysis, University Clinical Center Nis

Niš, Serbia

Korea University Ansan Hospital

Ansan, South Korea

St Mary's Incheon Hospital

Incheon, South Korea

Kangdong KyungHee University Hospital

Seoul, South Korea

St Mary's Seoul Hospital

Seoul, South Korea

St Mary's Yeouido Hospital

Seoul, South Korea

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Shuang Ho Hospital

New Taipei City, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Ege University Faculty of Medicine Hospital

Izmir, Turkey (Türkiye)

Erciyes University Faculty of Medicine Hospital

Kayseri, Turkey (Türkiye)

Kocaeli University Faculty of Medicine Hospital

Kocaeli, Turkey (Türkiye)

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