Myelodysplastic SyndromesPhase 2NCT07319845
A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes
A Phase 2 study testing TAK-226 in people with Myelodysplastic Syndromes, run by Takeda at 21 sites in Japan.
Trial summary
The main aim of the study is to evaluate how TAK-226 improves symptoms of transfusion-dependent anemia in Japanese patients with lower-risk myelodysplastic syndromes. The study consists of Screening Period (up to 6 weeks), Treatment Period, Safety Follow-Up Period (8 weeks), and Long-Term Follow-Up Period… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- TAK-226
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 21 sitesJapan
- Study dates
- 22 Apr 2026to 10 Jan 2033
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants or their legally authorized representative must be willing and able to sign the ICF and to adhere to the protocol requirements.
- Japanese adult male or female participant greater than or equal to (>=) 18 years of age at the time of signing informed consent.
- Diagnosis of MDS with or without ring sideroblasts (RS) (as determined in an evaluable bone marrow sample collected at screening to confirm diagnosis) according to WHO 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low-, low-, or intermediate-risk MDS.
- Note: Due to expected impacts of transfusion, hemoglobin (Hgb) values from blood samples collected within 14 days following a red blood cell (RBC) transfusion and platelet count obtained within 7 days following a platelet transfusion cannot be used for IPSS-R eligibility, unless considered pretransfusion values.
- Transfusion dependent (TD) cohort: Transfusion dependence assessed in the 16 weeks immediately preceding enrollment in two 8-week blocks classified as either:
- Low-transfusion burden (LTB), defined as 4 to 7 RBC units per 16 weeks; or
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- High-transfusion burden (HTB), defined as >=8 RBC units per 16 weeks; and
- For all participants:
- Only transfusion events for a pretransfusion Hgb <10 grams per deciliter (g/dL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week block and a minimum of 2 transfusion events separated by >=7 days within the 16-week period immediately preceding enrollment; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16 week period immediately preceding enrollment.
- Note: Only transfusions for the disease under study will be counted towards classification for LTB or HTB participants. Transfusions for intercurrent diseases (bleeding, surgical procedure, infection, etc.) are not considered.
- Non-transfusion dependent (NTD) cohort: NTD, defined as 0 to 1 RBC units per 8 weeks immediately preceding enrollment.
- Note: RBC transfusions administered when Hgb levels were <9.0 g/dL are counted for eligibility. RBC transfusions administered for other than MDS-related anemia (bleeding, surgical procedure, infection, etc.) will not be counted as a required transfusion for the purpose of meeting eligibility criteria.
- TD cohort: Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued >=4 weeks before enrollment), or unlikely to respond to ESA treatment, defined as follows:
- 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 (eg, with granulocyte colony-stimulating factor [G-CSF]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) >=30,000 IU/week for >=8 doses or equivalent; or ii. Darbepoetin alpha >=500 mcrg every 3 weeks for >=3 doses, >=120 mcrg every week for >=8 doses or equivalent.
- Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA containing regimen, either as a single agent or combination (eg, with G-CSF), at any time after introduction due to intolerance or an AE.
- Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level >200 U/L.
- Note: Due to expected impacts of transfusion on EPO levels, blood samples collected within the 14 days following an RBC transfusion or within 7 days following a platelet transfusion cannot be used to evaluate serum EPO level for eligibility, unless considered pretransfusion values.
- NTD cohort: Hgb <10 g/dL and exhibiting anemia-related clinical symptoms (eg, fatigue, shortness of breath, or others) during screening.
- Less than 5% blasts in an evaluable bone marrow sample collected at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Women of childbearing potential (WOCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must
- Agree to use 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 60 days after the last dose of study drug; or
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)
- Male participants must, even if he is surgically sterilized (ie, status postvasectomy), a. Agree to practice effective barrier contraception the time of signing the informed consent through 60 days after the last dose of study drug; or Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)
Who cannot join
- Medical History
- Del(5q) MDS or secondary MDS.
- Anemia due to any other known cause (eg, 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 in TD cohort or 8 weeks in NTD cohort before enrollment.
- Clinically significant cardiovascular disease defined as:
- New York Heart Association heart disease class III or IV;
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- Fridericia corrected QT (QTcF) interval >500 milliseconds during screening;
- Presence of uncontrolled hypertension defined as mean systolic blood pressure >=160 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.
- 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 the participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for >=2 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;
- Carcinoma in situ of the breast; and/or
- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system).
- Early papillary thyroid cancer (stage I [T1-T2, N0, M0]).
- History of solid organ or bone marrow transplantation.
- Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before enrollment.
- Active infection with HIV, active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants who are positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis B surface antibody (HBsAb) may be eligible for enrollment if their hepatitis B viral load is below the limit of detection. Participants who are positive for hepatitis C virus antibodies (HCVAb) may be enrolled if their hepatitis C viral load is below the limit of detection.
- Body mass index >=40 kg/m^2.
- Major surgery within 28 days before enrollment.
- History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept [TAK 226] IB for a list of excipients) or recombinant proteins.
- Treatment History
- TD cohort: Prior use of TAK 226, luspatercept, imetelstat, or sotatercept. NTD cohort: Prior use of TAK 226, luspatercept, imetelstat, sotatercept, or ESAs.
- Note for NTD cohort: At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of ESAs >=8 weeks prior to enrollment.
- Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, or immunosuppressive therapy given for treatment of MDS.
- Iron chelation therapy initiated within 8 weeks before enrollment. Participants on stable or decreasing doses of iron chelation therapy for >=8 weeks are allowed.
- Vitamin B12 or folate therapy initiated within 4 weeks before enrollment. Participants on stable replacement doses for >=4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
- Androgen use within 8 weeks before enrollment. Participants on stable androgen dosing for hypogonadism for >=8 weeks are allowed.
- High-dose systemic corticosteroid use within 4 weeks before enrollment. Participants on stable chronic steroid doses of prednisone/prednisolone <=10 mg/day or corticosteroid equivalent for >=4 weeks are allowed.
- Treatment with any investigational drug within 28 days before screening or, if the half-life of the product is known, within 5 times the half-life before screening, whichever is longer.
- Ongoing participation in another interventional clinical study.
- Laboratory Exclusions (during Screening)
- Serum EPO level >500 U/L. Note: Due to expected impacts of transfusion on EPO levels, laboratory results from blood samples collected within the 14 days following an RBC transfusion cannot be used to evaluate serum EPO level for eligibility, unless considered pretransfusion values.
- Platelet count >=800*10^3/mcrL or <=25*10^3/mcrL. Note: Due to expected impacts of transfusion, laboratory results from blood samples collected within the 7 days following a platelet transfusion cannot be used to evaluate platelet count for eligibility, unless they are considered pretransfusion values.
- Absolute neutrophil count <=500/mcrL
- Serum AST or ALT >=3*the upper limit of normal (ULN).
- Total bilirubin >=2*ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin <3*ULN are allowed.
- Ferritin <=50 mcrg/L.
- Folate <=2.0 ng/mL.
- Vitamin B12 <=200 pg/mL.
- Estimated glomerular filtration rate <30 mL/min/1.73 m^2 as determined by Japanese Society of Nephrology. Calculated by the correction formula for Japanese. a)
- eGFR=194* (serum creatinine value)^-1.094* (age)^-0.287* (sex correction factor), Sex correction factor: 0.739 in female.
- Miscellaneous
- Pregnant or lactating female. Note: Participants who may be in the very early stage of pregnancy based on the doctor's interview with a negative pregnancy test are excluded from the study. Participants who are lactating will be eligible if they discontinue breastfeeding from before the first dose of study drug until 60 days after the last dose of study drug.
- Any other condition not specifically noted above that, in the opinion of the investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.
- Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the investigator, employees of the Sponsor or contract research organization (CRO) directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Japan21 sites, 21 recruiting
- Not yet recruiting
National Hospital Organization Nagoya Medical Center
Aichi, Nagoya
- Not yet recruiting
Japanese Red Cross Narita Hospital
Chiba, Narita
- Recruiting
Matsuyama Red Cross Hospital
Ehime, Matsuyama
- Recruiting
University of Fukui Hospital
Fukui, Eiheiji
- Recruiting
JCHO Kyushu Hospital
Fukuoka, Kitakyushu
- Recruiting
National Hospital Organization Kyushu Medical Center
Fukuoka
- Recruiting
Gifu Municipal Hospital
Gifu
- Recruiting
Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
Hiroshima, Fukuyama
- Recruiting
Hokuyukai Sapporo Hokuyu Hospital
Hokkaido, Sapporo
- Not yet recruiting
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Hyōgo, Kobe
- Not yet recruiting
Tokai University Hospital
Kanagawa, Isehara
- Not yet recruiting
Kitasato University Hospital
Kanagawa, Sagamihara
- Not yet recruiting
National University Corporation Tohoku University Tohoku University Hospital
Miyagi, Sendai
- Not yet recruiting
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki
- Not yet recruiting
Okayama City General Medical Center Okayama City Hospital
Okayama
- Recruiting
Kindai University Hospital
Osaka, Sakai
- Not yet recruiting
Dokkyo Medical University Hospital
Tochigi, Mibu
- Not yet recruiting
Tokyo Metropolitan Komagome Hospital
Tokyo, Bunkyo-ku
- Recruiting
NTT Medical Center Tokyo
Tokyo, Shinagawa-ku
- Not yet recruiting
Yamagata University Hospital
Yamagata
- Not yet recruiting
Yamanashi Prefectural Central Hospital
Yamanashi, Kofu
About this study
Official title: A Phase 2, Multicenter, Open-Label, Single-arm Study to Evaluate the Efficacy and Safety of TAK-226 for Anemia in Japanese Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
The main aim of the study is to evaluate how TAK-226 improves symptoms of transfusion-dependent anemia in Japanese patients with lower-risk myelodysplastic syndromes.
The study consists of Screening Period (up to 6 weeks), Treatment Period, Safety Follow-Up Period (8 weeks), and Long-Term Follow-Up Period (approximately 5 years from the first dose of the study treatment).
Read more
Participants of this study will be administered TAK-226 during Treatment Period. Subsequently, the participants will be monitored for side effects related to the study treatment during Safety Follow-Up Period and Long-Term Follow-Up Period. The approximate duration of participation for a participant is up to approximately 6 years.
During the study period, participants will visit the study clinic/hospital multiple times as per the study schedule. During Treatment Period, the participants will come to the clinic/hospital approximately every two to four weeks.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- TAK-226
- Keywords
- Drug Therapy
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-226Drug
Also called Elritercept, KER-050
TAK-226 subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| TAK-226 | Experimental | Participants will receive the study drug, TAK-226, administered subcutaneously every four weeks (Q4W) for approximately one year during Treatment Period. Receives: Drug: TAK-226 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion dependent (TD) cohort: Percentage of Participants Achieving Transfusion Independence (TI) for Greater Than or Equal to (>=) 8 Weeks from Baseline through Week 24
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.
Measured: Baseline, Up to Week 24
Non-transfusion dependent (NTD) cohort: Percentage of Participants Achieving Mean Hgb Increase of >=1.5 grams per deciliter (g/dL) for >=8 Weeks from Baseline through Week 24 And No RBC Transfusion during the Same >=8 Weeks Period
Measured: Baseline, Up to Week 24
Secondary outcomes (62)
TD cohort: Percentage of Participants Achieving TI for >=24 Weeks from Baseline through Week 48
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 24 weeks after the first dose of the study treatment through week 48.
Measured: Baseline, Up to Week 48
TD cohort: Percentage of Participants with High Transfusion Burden (HTB) Achieving TI for >=8 Weeks from Baseline through Week 24
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Measured: Baseline, Up to Week 24
TD cohort: Percentage of Participants Achieving Mean Hemoglobin (Hgb) Increase of >=1.5 g/dL for >=8 Weeks from Baseline through Week 24
Measured: Baseline, Up to Week 24
TD cohort: Number of Participants with Treatment-Emergent Adverse Event (TEAEs) and Serious Adverse Event (SAEs)
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. A TEAE is defined as an AE that commences on or after the first dose of the study treatment and within 60 days after the last dose of the study treatment, or analysis cutoff date, whichever is earlier. An SAE is any untoward medical occurrence that, at any dose: results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
Measured: Up to approximately 6 years
TD cohort: Serum Concentration of TAK-226
TAK-226 time-concentration data will be assessed.
Measured: Baseline, and multiple time points up to the end of Treatment Period (approximately 12 months)
TD cohort: Number of Participants with Treatment-Emergent Anti-Drug Antibody (ADA)
Measured: Up to the end of Safety Follow-Up Period (approximately 14 months)
TD cohort: ADA Titer
Measured: Baseline, and multiple time points up to approximately 24 months
NTD cohort: Percentage of Participants Achieving Mean Hgb Increase of >=1.5 g/dL for >=12 Weeks from Baseline through Week 24 And No RBC Transfusion during the Same >=12 Weeks Period
Measured: Baseline, Up to Week 24
NTD cohort: Percentage of Participants Achieving Consecutive Hgb Increase of >=1.5 g/dL for >=8 Weeks from Baseline through Week 24 And No RBC Transfusion during the Same >=8 Weeks Period
Measured: Baseline, Up to Week 24
NTD cohort: Percentage of Participants Achieving Mean Hgb Increase of >=1.5 g/dL for >=16 Weeks from Baseline through Week 24 And through Week 48, And No RBC Transfusion during the Same >=16 Weeks Period
Measured: Baseline, Up to Week 24 and Week 48
NTD cohort: Number of Participants with TEAEs and SAEs
Measured: Up to approximately 6 years
TD and NTD cohorts: Change from baseline in Hematocrit
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Hemoglobin
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Red Cell Distribution Width
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Red Blood Cell
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Reticulocyte
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Platelet
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in White Blood Cell
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Neutrophils
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Eosinophils
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Basophils
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Lymphocytes
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Monocytes
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Mean Corpuscular Volume
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Mean Corpuscular Hemoglobin
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Mean Cell Hemoglobin Concentration
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Albumin
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Total Protein
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Blood Glucose
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Sodium
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Potassium
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Chloride
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Blood Urea Nitrogen
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Creatinine
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Aspartate Aminotransferase
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Alanine Aminotransferase
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Alkaline Phosphatase
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Gamma Glutamyl Transferase
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Total Bilirubin
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Lactate Dehydrogenase
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Calcium
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Magnesium
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Phosphorus
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Uric Acid
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Erythropoietin
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Thrombopoietin
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in N-Terminal Prohormone of Brain Natriuretic Protein
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Serum Iron
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Ferritin
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Transferrin
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Transferrin Saturation
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Total Iron Binding Capacity
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Soluble Transferrin Receptor
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Hepcidin
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Blood Pressure
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Heart Rate
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Respiratory Rate
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Body Temperature
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in PR Interval
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in QRS Duration
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in QT Interval
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in QTcF Interval
Measured: From the time of signing the informed consent form through safety follow-up, approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start22 Apr 2026
- Primary completion26 Jun 2028 (estimated)
- Study completion10 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319845
- Sponsor's protocol ID
- TAK-226-2001
- Other IDs
- jRCT2031250603
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.