Actively Recruiting
A Phase 3 Randomized Trial Comparing Elritercept and Epoetin Alfa for Treating Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes Who Need Red Blood Cell Transfusions
Led by Takeda · Updated on 2026-03-09
300
Participants Needed
146
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating elritercept compared to epoetin alfa to treat anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who need regular red blood cell (RBC) transfusions. The study aims to assess how elritercept affects the need for RBC transfusions, its safety, and whether it improves tiredness and quality of life compared to epoetin alfa. The trial also explores the immune response to elritercept and monitors medical problems related to the treatment. Participants will be randomly assigned to receive either elritercept or epoetin alfa. Those receiving elritercept will start with a dose of 3.75 mg/kg by subcutaneous injection every 4 weeks, which may be increased to 5.0 mg/kg if necessary. Participants receiving epoetin alfa will start at 450 IU/kg by subcutaneous injection once weekly, with possible dose escalation up to 1050 IU/kg. Treatment will continue with monitoring over several cycles, each lasting 28 days, with assessments up to 48 weeks and potential follow-up to about 5 years. During the study, participants will have regular visits to assess their need for RBC transfusions, hemoglobin levels, fatigue using the FACIT-Fatigue Scale, quality of life through questionnaires, and blood tests to monitor drug levels and immune response. The main outcome is the proportion of participants who become independent of RBC transfusions for at least 12 consecutive weeks with improved hemoglobin. Safety and overall health will be closely monitored, including tracking any progression to acute myeloid leukemia or death. The total participation duration may last up to several years to evaluate long-term effects.
CONDITIONS
Brief Title
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Able to understand and voluntarily sign informed consent
- Diagnosed with very low, low, or intermediate risk myelodysplastic syndromes (MDS) confirmed by central review
- Bone marrow blast count less than 5% at screening
- Endogenous serum erythropoietin level below 500 U/L
- Requires 2 to 6 red blood cell transfusions every 8 weeks for at least 8 weeks before randomization
- Hemoglobin less than 11.0 g/dL after last transfusion
- Eastern Cooperative Oncology Group score of 0, 1, or 2
You will not qualify if you...
- Prior therapy with epoetin alfa (more than 2 doses within 8 weeks), darbepoetin, certain growth factors, immunomodulatory drugs, hypomethylating agents, luspatercept, sotatercept, imetelstat, elritercept, immunosuppressive therapy, or hematopoietic cell transplant
- Myelodysplastic syndromes with del(5q) cytogenetic abnormality, unclassifiable MDS, or secondary MDS
- History of acute myeloid leukemia
- Anemia from other known causes such as nutritional deficiencies or hemolytic anemia
- Significant cardiovascular disease or low heart function
- History of recent thromboembolic events
- Uncontrolled high blood pressure
- Recent malignancies other than MDS unless treated and stable
- History of organ or bone marrow transplantation
- Active infection requiring recent antibiotic treatment
- Known positive for HIV, active hepatitis B or C infection
- Body mass index 40 or higher
- Major surgery within 28 days prior to randomization
- Recent seizures or poorly controlled seizures
- Allergy to study drugs or related proteins
- History of pure red cell aplasia or antibodies against erythropoietin
- Certain abnormal laboratory test results
- Participation in another interventional clinical trial
- Unwillingness or inability to comply with the study protocol
- Not agreeing to use effective contraception if of childbearing potential
- Special legal or social status for participants in France
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive study drug injections either Elritercept once every 4 weeks or Epoetin Alfa once every week to treat anemia associated with myelodysplastic syndromes.
Weekly visits for up to 48 weeks
Duration - Approximately 4 years after treatment
Participants are monitored for safety and treatment outcomes after completing the treatment phase.
Visits approximately every 3 months for up to 5 years total participation
Trial Site Locations
Total: 146 locations
1
Hematology-Oncology Medical Group of Orange County, Inc - Orange - 1010 W. La Veta Avenue
Orange, California, United States, 92868
Not Yet Recruiting
2
BRCR Medical Center Inc
Tamarac, Florida, United States, 33321
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
4
Orchard Healthcare Research Inc. (OHR) - Skokie
Skokie, Illinois, United States, 60077
Actively Recruiting
5
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Not Yet Recruiting
6
American Oncology Partners P.A. MidAmerica Cancer Care
Kansas City, Missouri, United States, 64132
Not Yet Recruiting
7
Albert Einstein College - Montefiore
The Bronx, New York, United States, 10467
Not Yet Recruiting
8
Novant Health Care Institute
Winston-Salem, North Carolina, United States, 27106
Not Yet Recruiting
9
Cleveland clinic OH
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
10
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Not Yet Recruiting
11
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
12
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
13
World Research Link
Baytown, Texas, United States, 77521
Not Yet Recruiting
14
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
15
The University of Texas-MD Anderson Cancer Center - Leukemia Center
Houston, Texas, United States, 77030
Not Yet Recruiting
16
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84124
Not Yet Recruiting
17
Virginia Commonwealth University (VCU)-Medical Center - North Hospital
Richmond, Virginia, United States, 23298
Not Yet Recruiting
18
West Virginia University Cancer Institute
Wheeling, West Virginia, United States, 26003
Not Yet Recruiting
19
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina, 2000
Not Yet Recruiting
20
Swiss Medical Center - Barrio Parque
Buenos Aires, Argentina, 1425
Not Yet Recruiting
21
Sanatorio Allende S.A. - Nueva Cordoba
Córdoba, Argentina, 5000
Not Yet Recruiting
22
Hospital Privado de Cordoba
Córdoba, Argentina, X5000
Not Yet Recruiting
23
Mid North Coast Local Health District - Mid North Coast Cancer Institute (MNCCI) - Coffs Harbour
Coffs Harbour, New South Wales, Australia, 2450
Not Yet Recruiting
24
South Eastern Sydney Local Health District
Sydney, New South Wales, Australia, 2217
Not Yet Recruiting
25
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2282
Not Yet Recruiting
26
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Not Yet Recruiting
27
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Not Yet Recruiting
28
Monash University-Monash Medical Centre (MMC) - Clayton
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
29
Eastern Haematology & Oncology Group or Austin Hospital
Heidelberg, Victoria, Australia, 3084
Not Yet Recruiting
30
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Not Yet Recruiting
31
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Not Yet Recruiting
32
Chu-Ucl Namur Site Godinne
Yvoir, Namur, Belgium, 5530
Not Yet Recruiting
33
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Not Yet Recruiting
34
AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke
Roeselare, West Flanders, Belgium, 8800
Not Yet Recruiting
35
D'OR Institute for Research and Education
Salvador, Estado de Bahia, Brazil, 41253-190
Not Yet Recruiting
36
Santa Casa de Misericordia-Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90020090
Not Yet Recruiting
37
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Not Yet Recruiting
38
Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
Not Yet Recruiting
39
Centro de Hematologia e Oncologia (CHO)
Joinville, Santa Catarina, Brazil, 89201-260
Not Yet Recruiting
40
Hospital Amaral Carvalho (HAC)
Jaú, São Paulo, Brazil, 17210080
Not Yet Recruiting
41
Irmandade da Santa Casa da Misericordia de Santos (ISCMS)
Santos, São Paulo, Brazil, 11075-101
Not Yet Recruiting
42
Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
São Paulo, Brazil, 01321-001
Not Yet Recruiting
43
Hospital 9 de Julho (Rede Americas/DASA)
São Paulo, Brazil, 01409-000
Not Yet Recruiting
44
Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
Plovdiv, Bulgaria, 4000
Not Yet Recruiting
45
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
Sofia, Bulgaria, 1756
Not Yet Recruiting
46
St. Paul's Hospital (SPH) - Vancouver
Vancouver, British Columbia, Canada, V6E 1M7
Not Yet Recruiting
47
London Health Sciences Centre (LHSC) - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Not Yet Recruiting
48
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
49
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Isere, France, 38700
Not Yet Recruiting
50
Poitiers University Hospital Center - Miletrie Site
Poitiers, Vienne, France, 86021
Not Yet Recruiting
51
Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique
Nice, France, 06200
Not Yet Recruiting
52
Saint-Louis Hospital
Paris, France, 75010
Not Yet Recruiting
53
Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
54
Universitatsklinikum Bayreuth, Med. Klinik IV
Bayreuth, Bavaria, Germany, 95445
Not Yet Recruiting
55
Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse
Münster, North Rhine-Westphalia, Germany, 48153
Not Yet Recruiting
56
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
Halle, Saxony-Anhalt, Germany, 06120
Not Yet Recruiting
57
Praxis am Volkspark
Berlin, Germany, 10715
Not Yet Recruiting
58
Charite Campus Benjamin Franklin
Berlin, Germany, 12200
Not Yet Recruiting
59
Laiko General Hospital
Athens, Central Athens, Greece, 11526
Not Yet Recruiting
60
National and Kapodistrian University of Athens (NKUA)-Laiko General Hospital
Goudi, Central Athens, Greece, 11527
Not Yet Recruiting
61
Democritus University of Thrace (DUTH) - University General Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece, 68100
Not Yet Recruiting
62
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, Macedonia, Greece, 55133
Not Yet Recruiting
63
National and Kapodistrian University of Athens-University General Hospital Attikon
Athens, West Athens, Greece, 12462
Not Yet Recruiting
64
Faculty of Medicine, School of Health Sciences, University of Ioannina
Ioannina, Greece, 45500
Not Yet Recruiting
65
University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
Debrecen, Hajdú-Bihar, Hungary, 4032
Not Yet Recruiting
66
Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology
Tatabánya, Komárom-Esztergom, Hungary, 2800
Not Yet Recruiting
67
AIMS, Kochi
Kochi, Kerala, India, 682041
Not Yet Recruiting
68
Sahyadri Hospitals, Pune
Pune, Maharashtra, India, 411004
Not Yet Recruiting
69
Christian Medical College
Vellore, Tamil Nadu, India, 632517
Not Yet Recruiting
70
Apollo Hospital Hyderabad
Hyderabad, Telangana, India, 500096
Not Yet Recruiting
71
Tata Medical Center, Kolkata
Kolkata, West Bengal, India, 700160
Not Yet Recruiting
72
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh, India, 160012
Not Yet Recruiting
73
Max SuperSpeciality Saket, Delhi
Delhi, India, 110017
Not Yet Recruiting
74
Cork University Hospital
Cork, Ireland, T12 DC4A
Not Yet Recruiting
75
Mater Misericordiae University Hospital
Dublin, Ireland, Dublin 7
Not Yet Recruiting
76
Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"
Bologna, Italy, 40138
Not Yet Recruiting
77
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence, Italy, 50141
Not Yet Recruiting
78
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
79
Ospedale Cardarelli
Naples, Italy, 80131
Not Yet Recruiting
80
Ospedale di Novara
Novara, Italy, 28100
Not Yet Recruiting
81
Universita degli Studi di Padova-Azienda Ospedaliera di Padova
Padova, Italy, 35128
Not Yet Recruiting
82
Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
Pavia, Italy, 27100
Not Yet Recruiting
83
Universita Degli Studi di Roma "Tor Vergata"
Rome, Italy, 00133
Not Yet Recruiting
84
Policlinico Umberto I
Rome, Italy, 00161
Not Yet Recruiting
85
Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas)
Rozzano, Italy, 20089
Not Yet Recruiting
86
Institute of Cancer Research and Treatment of Candiolo
Torino, Italy, 10060
Not Yet Recruiting
87
NHO Nagoya Medical Center
Naka-ku, Aichi-ken, Japan, 460-0001
Not Yet Recruiting
88
Gifu Municipal Hospital
Gifu, Gifu, Japan, 500-8323
Not Yet Recruiting
89
Chugoku Central Hospital
Fukuyama, Hiroshima, Japan, 720-0001
Not Yet Recruiting
90
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, Japan, 660-8550
Not Yet Recruiting
91
Dokkyo Medical University Hospital
Kitakobayashi, Tochigi, Japan, 321-0293
Not Yet Recruiting
92
Fukushima Medical University Hospital
Fukushima, Tohoku, Japan, 960-1295
Not Yet Recruiting
93
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
Not Yet Recruiting
94
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan, 141-8625
Not Yet Recruiting
95
Hospital of Lithuania University of Health Sciences Kaunas, Clinic of Oncology and Hematology
Kaunas, Lithuania, 50161
Not Yet Recruiting
96
Vilniaus Universiteto Ligonine Santaros Klinikos (VULSK) (Vilniaus Universiteto Ligonines Santariskiu Klinikos)
Vilnius, Lithuania, 08661
Not Yet Recruiting
97
Hospital Sultanah Aminah Johor Bahru (HSAJB)
Johor Bahru, Johor, Malaysia, 80100
Not Yet Recruiting
98
Hospital Sultanah Bahiyah (HSB) (Klinik Kesihatan Bandar Alor Setar/Hospital Alor Setar)
George Town, Kedah, Malaysia, 11450
Not Yet Recruiting
99
Universiti Malaya - Faculty of Medicine (FOM)
Kuala Lumpur, Kuala Lumpur, Malaysia, 59200
Not Yet Recruiting
100
Centro de Investigacion Clinica Chapultepec (CICC), S.A. de C.V
Morelia, Michoacán, Mexico, 58260
Not Yet Recruiting
101
Universidad Autonoma de Nuevo Leon-Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Servicio de Hematologia
Monterrey, Nuevo León, Mexico, 64460
Not Yet Recruiting
102
Oaxaca Site Management Organization S.C. - Oaxaca
Oaxaca City, Oaxaca, Mexico, 68000
Not Yet Recruiting
103
National Institute of Medical Sciences and Nutrition Salvado
México, Mexico, 14080
Not Yet Recruiting
104
Clinica Ruiz - Centro de Hematologia y Medicina Interna (CHMI)
Puebla City, Mexico, 72530
Not Yet Recruiting
105
Amsterdam UMC-Locatie VUMC (Vrije Universiteit Medisch Centrum)
Amsterdam, North Holland, Netherlands, 1081HV
Not Yet Recruiting
106
Sykehuset Vestfold HF
Tønsberg, Vestfold, Norway, 3116
Not Yet Recruiting
107
Helse Bergen HF
Bergen, Vest, Norway, 5021
Not Yet Recruiting
108
Oslo Universitetssykehus HF
Oslo, Norway, 0372
Not Yet Recruiting
109
Pratia Wroclaw
Wroclaw, Lower Silesian Voivodeship, Poland, 50-019
Not Yet Recruiting
110
Pratia MCM Krakow
Krakow, maAopolska, Poland, 50-727
Not Yet Recruiting
111
Warszawski Uniwersytet Medyczny (WUM) (Medical University of Warsaw)
Warsaw, Masovian Voivodeship, Poland, 02-172
Not Yet Recruiting
112
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, Poland, 40-519
Not Yet Recruiting
113
AidPort
Skorzewo, Wielkopolska, Poland, 60185
Not Yet Recruiting
114
Institutul Oncologic Prof. Dr. I. Chiricu
Cluj-Napoca, Cluj, Romania, 400124
Not Yet Recruiting
115
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Not Yet Recruiting
116
Soon Chun Hyang University Hospital Seoul
Seoul, Yongsan-gu, South Korea, 04401
Not Yet Recruiting
117
Korea University Anam Hospital
Seoul, South Korea, 02841
Not Yet Recruiting
118
Seoul National University Hospital
Seoul, South Korea, 03080
Not Yet Recruiting
119
Samsung Medical Center
Seoul, South Korea, 06351
Not Yet Recruiting
120
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Not Yet Recruiting
121
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals Location
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Not Yet Recruiting
122
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, Seville, Spain, 41013
Not Yet Recruiting
123
Hospital Universitari Vall d'Hebron-Institut de Recerca (VHIR)
Barcelona, Spain, 08035
Not Yet Recruiting
124
University Hospital Ramon y Cajal
Madrid, Spain, 28034
Not Yet Recruiting
125
Hospital Universitario Virgen de la Victoria (HUVV)
Málaga, Spain, 29010
Not Yet Recruiting
126
Universidad de Salamanca - Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Not Yet Recruiting
127
University and Polytechnic Hospital La Fe
Valencia, Spain, 46026
Not Yet Recruiting
128
Chang Bing Show Chwan Memorial Hospital
Changhua, Taiwan, 505029
Not Yet Recruiting
129
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Not Yet Recruiting
130
China Medical University Hospital
Taichung, Taiwan, 404
Not Yet Recruiting
131
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Not Yet Recruiting
132
National Taiwan University Hospital - East Campus
Taipei, Taiwan, 100225
Not Yet Recruiting
133
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Not Yet Recruiting
134
Banphaeo General Hospital
Ban Phaeo, Samutsakorn, Thailand, 74120
Not Yet Recruiting
135
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Not Yet Recruiting
136
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, Thailand, 50200
Not Yet Recruiting
137
Ondokuz Mayis University School of Medicine, Department of Hematology
Samsun, Atakum, Turkey (Türkiye), 55270
Not Yet Recruiting
138
Mersin Medicalpark Hospital
Mersin, Mezitli, Turkey (Türkiye), 33000
Not Yet Recruiting
139
Ankara Universitesi, TAp FakAltesi, Hematoloji BD
Ankara, Turkey (Türkiye), 06520
Not Yet Recruiting
140
Istanbul Florence Nightingale Hospital
Istanbul, Turkey (Türkiye), 34381
Not Yet Recruiting
141
Ege University Medical Faculty
Izmir, Turkey (Türkiye), 35100
Not Yet Recruiting
142
Pilgrim Hospital
Boston, Lincolnshire, United Kingdom, PE227BU
Not Yet Recruiting
143
Churchill Hospital
Oxford, OXON, United Kingdom, OX3 7LE
Not Yet Recruiting
144
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH
Not Yet Recruiting
145
King's College Hospital
London, United Kingdom, SE5 9RS
Not Yet Recruiting
146
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Not Yet Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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