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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
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
Conditions
Interventions
Elritercept
Elritercept, SC injection.
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