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RECRUITING
NCT07422480
PHASE3

A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

The main aim of this study is to assess how much elritercept reduces the need for RBC (red blood cell) transfusions and improves hemoglobin blood values in addition to how safe elritercept is when compared with epoetin alfa. Other key aims are to learn how much elritercept improves tiredness and quality of life as reported by participants compared with epoetin alfa; to assess what risks (side effects) and how often they occur with elritercept compared with epoetin alfa. The study will also collect information for researchers to see how the disease in the bone marrow or other body areas may be affected by elritercept compared with epoetin alfa to try to learn how to better treat this disease.

Official title: A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-05-21

Completion Date

2033-10-01

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DRUG

Elritercept

Elritercept, SC injection.

DRUG

Epoetin Alfa

Epoetin Alfa, SC injection.

Locations (162)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope - Comprehensive Cancer Center (CCC)

Duarte, California, United States

Providence Medical Group

Santa Rosa, California, United States

Cancer & Blood Research Center

Whittier, California, United States

Yale

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States

BRCR Medical Center Inc

Tamarac, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Orchard Healthcare Research Inc. (OHR) - Skokie

Skokie, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Epic Medical Research

Monroe, Louisiana, United States

Epic Medical Research - Shreveport

Shreveport, Louisiana, United States

The Cancer and Hematology Centers

Grand Rapids, Michigan, United States

American Oncology Partners P.A. MidAmerica Cancer Care

Kansas City, Missouri, United States

Hematology Oncology Associates of Rockland

Nyack, New York, United States

Albert Einstein College - Montefiore

The Bronx, New York, United States

Novant Health Care Institute

Winston-Salem, North Carolina, United States

Cleveland clinic OH

Cleveland, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

World Research Link

Baytown, Texas, United States

Texas Oncology - Denton

Denton, Texas, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

The University of Texas-MD Anderson Cancer Center - Leukemia Center

Houston, Texas, United States

LUMI Research

Houston, Texas, United States

Renovatio Clinical

The Woodlands, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Commonwealth University (VCU)-Medical Center - North Hospital

Richmond, Virginia, United States

West Virginia University Cancer Institute

Wheeling, West Virginia, United States

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

Swiss Medical Center - Barrio Parque

Buenos Aires, Argentina

Sanatorio Allende S.A. - Nueva Cordoba

Córdoba, Argentina

Hospital Privado de Cordoba

Córdoba, Argentina

Mid North Coast Local Health District - Mid North Coast Cancer Institute (MNCCI) - Coffs Harbour

Coffs Harbour, New South Wales, Australia

South Eastern Sydney Local Health District

Sydney, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Monash University-Monash Medical Centre (MMC) - Clayton

Clayton, Victoria, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Eastern Haematology & Oncology Group or Austin Hospital

Heidelberg, Victoria, Australia

Alfred Hospital

Richmond, Victoria, Australia

Fiona Stanley Hospital

Perth, Western Australia, Australia

Chu-Ucl Namur Site Godinne

Yvoir, Namur, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke

Roeselare, West Flanders, Belgium

D'OR Institute for Research and Education

Salvador, Estado de Bahia, Brazil

Porto Alegre Clinical Hospital (HCPA)

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Mae de Deus, Clinical Research Unit - Cancer Institute

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Hematologia e Oncologia (CHO)

Joinville, Santa Catarina, Brazil

Hospital Amaral Carvalho (HAC)

Jaú, São Paulo, Brazil

Irmandade da Santa Casa da Misericordia de Santos (ISCMS)

Santos, São Paulo, Brazil

Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center

São Paulo, Brazil

Hospital 9 de Julho (Rede Americas/DASA)

São Paulo, Brazil

Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)

Plovdiv, Bulgaria

Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology

Sofia, Bulgaria

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isere, France

Poitiers University Hospital Center - Miletrie Site

Poitiers, Vienne, France

Gustave Roussy

Villejuif, X, France

Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique

Nice, France

Saint-Louis Hospital

Paris, France

Universitatsklinikum Bayreuth, Med. Klinik IV

Bayreuth, Bavaria, Germany

Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse

Münster, North Rhine-Westphalia, Germany

University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology

Halle, Saxony-Anhalt, Germany

Praxis am Volkspark

Berlin, Germany

Charite Campus Benjamin Franklin

Berlin, Germany

Laiko General Hospital

Athens, Central Athens, Greece

National and Kapodistrian University of Athens (NKUA)-Laiko General Hospital

Athens, Central Athens, Greece

Democritus University of Thrace (DUTH) - University General Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

General Hospital of Thessaloniki "Ippokratio"

Thessaloniki, Macedonia, Greece

National and Kapodistrian University of Athens-University General Hospital Attikon

Athens, West Athens, Greece

Faculty of Medicine, School of Health Sciences, University of Ioannina

Ioannina, Greece

University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology

Debrecen, H-B, Hungary

Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology

Tatabánya, Komárom-Esztergom, Hungary

AIMS, Kochi

Kochi, Kerala, India

Tata Medical Center, Kolkata

Kochi, Kerala, India

Sahyadri Hospitals, Pune

Pune, Maharashtra, India

Christian Medical College

Vellore, Tamil Nadu, India

Apollo Hospital Hyderabad

Hyderabad, Telangana, India

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

Chandigarh, India

Max SuperSpeciality Saket, Delhi

Delhi, India

Cork University Hospital

Cork, Ireland

St. James's Hospital

Dublin, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

University Hospital Galway

Galway, Ireland

Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)

Florence, Florence, Italy

Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas)

Rozzano, Milan, Italy

Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology

Pavia, PV, Italy

Policlinico Umberto I

Roma, Rome, Italy

Institute of Cancer Research and Treatment of Candiolo

Candiolo, Torino, Italy

Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"

Bologna, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Ospedale Cardarelli

Naples, Italy

Ospedale di Novara

Novara, Italy

Universita degli Studi di Padova-Azienda Ospedaliera di Padova

Padua, Italy

Universita Degli Studi di Roma "Tor Vergata"

Rome, Italy

NHO Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan, Japan

And 62 more locations on ClinicalTrials.gov