A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)
2 other identifiers
interventional
225
25 countries
155
Brief Summary
The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2025
Longer than P75 for phase_3
155 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedStudy Start
First participant enrolled
May 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2032
March 11, 2026
March 1, 2026
3 years
July 5, 2024
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Baseline through Week 24
Secondary Outcomes (4)
Percentage of Participants Achieving TI for ≥24 Weeks
Baseline through Week 48
Percentage of Participants with High-transfusion Burden (HTB) Achieving TI for ≥8 weeks
Baseline through Week 24
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From the time of signing the informed consent form through 60 days after the last dose of study treatment, approximately 6 years
Change from Baseline in Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)
From the time of signing the informed consent form through safety follow-up, approximately 16 months
Study Arms (2)
Elritercept
EXPERIMENTALParticipants will be administered elritercept (TAK-226, KER-050), subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period.
Placebo
PLACEBO COMPARATORParticipants will be administered elritercept (TAK-226, KER-050) matching-placebo, subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period.
Interventions
Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks.
Eligibility Criteria
You may qualify if:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.
- Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.
- Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.
- Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:
- a. Low-transfusion burden (LTB), defined as 4 to 7 red blood cells (RBC) units per 16 weeks; or b. High-transfusion burden (HTB), defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (\<)10 grams per deciliter (g/dL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.
- Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:
- a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor \[G-CSF\]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥40,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥4 doses or equivalent.
- b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.
- c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (\>)200 units per liter (U/L).
- Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.
- In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).
You may not qualify if:
- Del(5q) MDS or therapy-related (secondary) MDS.
- Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
- Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.
- Clinically significant cardiovascular disease defined as:
- New York Heart Association heart disease class III or IV;
- Fridericia corrected QT (QTcF) interval \>500 milliseconds during Screening;
- Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or
- Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.
- Known ejection fraction \<35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.
- Child-Pugh class C hepatic impairment.
- Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.
- Any known history of acute myeloid leukemia (AML).
- Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 5 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:
- Basal or squamous cell carcinoma of the skin;
- Carcinoma in situ of the cervix;
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (155)
City of Hope
Duarte, California, 91010, United States
Los Angeles Cancer Network
Glendale, California, 91206, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92037, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06511, United States
University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
ILCC. Illinois Cancer Centers
Peoria, Illinois, 61645, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Maryland Oncology Hematolofy
Columbia, Maryland, 21044, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89169, United States
Clinical Research Alliance NY
Westbury, New York, 11590, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Cleveland Clinic - Cleveland
Cleveland, Ohio, 44195, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Baptist Clinical Research Institute
Memphis, Tennessee, 38120, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Oncology Northeast Texas
Denison, Texas, 75020, United States
U.T. MD Anderson Cancer Center, Division of Cancer Medicine
Houston, Texas, 77030, United States
Texas Oncology Gulf Coast
The Woodlands, Texas, 77380, United States
Tranquil Research
Webster, Texas, 77598-4085, United States
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Townsville University Hospital
Douglas, Queensland, 4814, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
St Vincent's Hospital (Melbourne) Ltd
Fitzroy, Victoria, 3065, Australia
Peter MacCallum Cancer Center
Parkville, Victoria, 3000, Australia
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Sao Jose do Rio Preto Regional Faculty of Medicine Foundation
São José do Rio Preto, São Paulo, 15090-000, Brazil
Americas Institute
Rio de Janeiro, 22775-001, Brazil
Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
São Paulo, 01323-900, Brazil
Hospital A.C.Camargo ("Antonio Prudente" Foundation)
São Paulo, 01509-900, Brazil
Santa Casa of Mercy of Santos
São Paulo, 11075-900, Brazil
Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
Plovdiv, 4002, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
Sofia, 1431, Bulgaria
Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy, Clinic of Hematology
Sofia, 1606, Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
Sofia, 1797, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Clinical Hematology
Varna, 9010, Bulgaria
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Providence Hematology - Vancouver
Vancouver, British Columbia, V6Z 2A5, Canada
Nova Scotia Health Authority, Centre for Clinical Research
Halifax, Nova Scotia, B3H 1V7, Canada
London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
Sunnybrook Research Institute, Odette Cancer Center
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Dr. Guillermo Grant Benavente - Concepcion Regional Hospital
Concepción, Bio Bio, 4070356, Chile
IC La Serena Research
La Serena, Coquimbo Region, 1720430, Chile
SAGA Clinical Research Center SpA
Santiago, 7500653, Chile
Clinic Inmunocel
Santiago, 7580206, Chile
Center for Clinical Studies and Medical Research (CECIM)
Santiago, 8320000, Chile
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
Brno, 625 00, Czechia
University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
Hradec Králové, 500 05, Czechia
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
Prague, 100 00, Czechia
Institute of Hematology and Blood Transfusion, Division of Training and Development
Prague, 12800, Czechia
Archet 1 and 2 hospital
Nice, 06200, France
Saint-Louis Hospital
Paris, 75010, France
Poitiers University Hospital Center - Miletrie Site
Poitiers, 86000, France
IUCT-Oncopole
Toulouse, 31059, France
University Hospital Bronn
Bonn, North Rhine-Westphalia, 53127, Germany
Marien Hospital Duesseldorf GmbH, Clinic for Oncology, Hematology and Palliative Medicine
Düsseldorf, North Rhine-Westphalia, 40479, Germany
University Hospital Leipzig, Clinic and Policlinic for Internal Medicine I Haematology and Stem Cell Therapy, Medical Oncology, Haemostaseology
Leipzig, Saxony, 04103, Germany
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
Halle, Saxony-Anhalt, 06120, Germany
University Clinic of Hematology, Oncology and Cell Therapy
Magdeburg, Saxony-Anhalt, 39120, Germany
Praxis am Volkspark Berlin
Berlin, 10715, Germany
Charite Universitatsmedizin Berlin
Berlin, 12203, Germany
Semmelweis University, Department of Internal Medicine and Haematology, Division of Hematology
Budapest, H-1088, Hungary
University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
Debrecen, 4032, Hungary
Mor Kaposi General Hospital, Department of Hematology
Kaposvár, H-7400, Hungary
Szabolcs-Szatmar-Bereg County Teaching Hospital, Department of Hematology
Nyíregyháza, 4400, Hungary
Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology
Székesfehérvár, H-8000, Hungary
Heamto Oncology Clinic Ahmedabad Pvt. Ltd.
Ahmedabad, Gujarat, 380009, India
Apollo Hospital International Ltd
Ahmedabad, Gujarat, 382428, India
Fortis Memorial Research Institute
Gurgaon, Haryana, 122002, India
Amrita Institute of Medical Sciences
Ernākulam, Kerala, 682041, India
Tata Memorial Centre
Mumbai, Maharashtra, 400012, India
Christian Medical College, Ludhianana
Ludhiana, Punjab, 380006, India
Christian Medical College
Vellore, Tamil Nadu, 632004, India
Max Super Speciality Hospital Vaishali (A Unit Of Crosslay Remedies Ltd.)
Ghaziabad, Uttar Pradesh, 201012, India
NRS Medical College and Hospital
Kolkata, West Bengal, 700014, India
Tata Medical Center, Kolkata
Kolkata, West Bengal, 700156, India
Postgraduate Institute of Medical Education and Research
Chandigarh, 160 012, India
Rajiv Gandhi Cancer Institute & Research Centre
Delhi, 110085, India
Medanta the Medicity
Gūrgaon, 122018, India
Cork University Hospital
Cork, T12 DC4A, Ireland
Beaumont Hospital
Dublin, D05 DK31, Ireland
Mater Misericordiae University Hospital
Dublin, D07 R2WY, Ireland
Tallaght University Hospital
Dublin, D24 NR0A, Ireland
St Vincent's University Hospital (SVUH)
Dublin, DO4 T6F4, Ireland
University Hospital Limerick
Limerick, V94 F858, Ireland
Hadassah Medical Center, Department of Hematology
Jerusalem, 9112001, Israel
Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center, Department of Hematology, Myelodysplastic Syndromes Center
Ramat Gan, 5266202, Israel
The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation, Leukemia Service
Tel Aviv, 6423906, Israel
Careggi University Hospital
Florence, 50134, Italy
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, 20122, Italy
Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
Pavia, 27100, Italy
Foundation PTV - Polyclinic Tor Vergata
Rome, 00133, Italy
Clinical Institute Humanitas, IRCCS
Rozzano, 20089, Italy
Institute of Cancer Research and Treatment of Candiolo
Turin, 10060, Italy
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, LT-50161, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08406, Lithuania
Edgardo Rebagliati Martins National Hospital
Lima, Jesus Maria, 15073, Peru
Anglo American Clinic
Lima, La Molina, 15023, Peru
IPOR: Peruvian Institute of Oncology & Radiotherapy
Lima, San Isidro Lima, 02002, Peru
Daniel Alcides Carrion National Hospital
Bellavista, 07016, Peru
National Institute of Neoplastic Diseases
Lima, 15038, Peru
Pratia Oncology Katowice
Katowice, 40-519, Poland
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, General Hematology Unit
Lodz, 93-513, Poland
Clinical Hospital Of The Ministry Of Internal Affairs And Administration With Warmia And Mazury Oncology Centre In Olsztyn, Clinical Department of Hematology and Internal Medicine with Bone Marrow Transplantation Center
Olsztyn, 10-228, Poland
Haemalife
Cape Town, 7580, South Africa
Capital Haematology Hospital
Durban, 4091, South Africa
Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center
Johannesburg, 2193, South Africa
Alberts Cellular Therapy
Pretoria, 0181, South Africa
Kyungpook National University Hospital
Daegu, 41944, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, 04401, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
University Clinical Hospital of Salamanca, Department of Hematology
Salamanca, Castille and León, 37007, Spain
University Hospital Vall d'Hebron, Department of Hematology
Barcelona, Catalonia, 08035, Spain
Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Clinical Hematology
L'Hospitalet de Llobregat, Girona, 08908, Spain
University Hospital Ramon y Cajal
Madrid, Madrid, 28034, Spain
University Hospital Foundation Jimenez Diaz
Madrid, Madrid, 28040, Spain
University and Polytechnic Hospital La Fe
Valencia, Valencia, 46026, Spain
Karolinska University Hospital
Huddinge, Stockholm County, 141 57, Sweden
Skane University Hospital - Lund, Department of Hematology and Vascular Disorders
Lund, 221 85, Sweden
Changhua Christian Hospital
Changhua, Changhua County, 500209, Taiwan
Chang Bing Show Chwan Memorial Hospital
Changhua, Changhua County, 50544, Taiwan
Taichung Veterans General Hospital
Taichung, 407219, Taiwan
National Cheng Kung University Hospital
Tainan, 704302, Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Banphaeo General Hospital
Bangkok, 74210, Thailand
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, 50200, Thailand
Adana City Hospital
Adana, 01370, Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, 06170, Turkey (Türkiye)
Ankara University Medical Faculty Cebeci Hospital
Ankara, 06600, Turkey (Türkiye)
Antalya Education and Training Hospital
Antalya, 07100, Turkey (Türkiye)
Mersin Medicalpark Hospital
Mersin, 33200, Turkey (Türkiye)
Sakarya University Medical Faculty Hospital
Sakarya, 54290, Turkey (Türkiye)
Ondokuz Mayis University School of Medicine, Department of Hematology
Samsun, 55139, Turkey (Türkiye)
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Sarah Cannon Research Institute (SCRI)
London, W1G 6AD, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This is a double-blind study in which treatment assignment will be blinded for the Participant, care provider, Investigators and any personnel (other than the selected unblinded personnel) involved with the study conduct or evaluation at the investigational sites, the CRO, and the Sponsor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2024
First Posted
July 12, 2024
Study Start
May 6, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2032
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.