A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes (NCT07319845) | Clinical Trial Compass
RecruitingPhase 2
A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes
Japan42 participantsStarted 2026-04-22
Plain-language 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 (5 years from the first dose of the study drug or 3 years after the last dose, whichever is longer).
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 \>=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 aspirate 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.
. TD\[YY1.1\] 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Transfusion dependent (TD) cohort: Percentage of Participants Achieving Transfusion Independence (TI) for Greater Than or Equal to (>=) 8 Weeks from Baseline through Week 24
Timeframe: Baseline, Up to Week 24
2
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
. HTB\[YY2.1\], defined as \>=8 RBC units per 16 weeks; and
. For all participants: i. Only transfusion events for a pretransfusion Hgb \<10 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.
. 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:
Exclusion criteria
. Del(5q) MDS or therapy-related (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;
. 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.