Dapagliflozin for Anemia in Lower-Risk Myelodysplastic Syndromes (NCT07516847) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Dapagliflozin for Anemia in Lower-Risk Myelodysplastic Syndromes
37 participantsStarted 2026-09
Plain-language summary
This study is a prospective, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of dapagliflozin in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS).
Anemia is the most common clinical problem in patients with lower-risk MDS and often leads to fatigue, reduced quality of life, and the need for repeated blood transfusions. Current treatment options, including erythropoiesis-stimulating agents and other therapies, are not effective in all patients, and additional treatment options are needed.
Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that is widely used for the treatment of diabetes, heart failure, and chronic kidney disease. Previous studies have shown that SGLT2 inhibitors can increase hemoglobin levels, possibly by stimulating erythropoiesis.
In this study, eligible patients will receive dapagliflozin 10 mg orally once daily for 24 weeks. The primary objective is to evaluate the hemoglobin response rate during the study period. Secondary objectives include changes in hemoglobin levels, transfusion requirements, and safety outcomes.
This study aims to explore whether dapagliflozin can serve as a potential treatment option for anemia in patients with lower-risk MDS.
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:
* Adults aged ≥18 years
* Diagnosis of myelodysplastic syndromes (MDS) according to WHO or ICC criteria
* Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk
* Hemoglobin ≤10 g/dL at screening
* Transfusion independent or low transfusion burden (Defined as ≤2 units of red blood cell transfusion within 8 weeks prior to enrollment)
* If receiving erythropoiesis-stimulating agents (ESA) or other anemia-directed therapy, on a stable dose for at least 8 weeks prior to enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Absolute neutrophil count (ANC) ≥0.75 ×10⁹/L
* Platelet count ≥50 ×10⁹/L
* Adequate organ function:
Creatinine clearance ≥30 mL/min AST or ALT ≤3 × upper limit of normal
Exclusion Criteria:
* IPSS-R intermediate-high or high-risk MDS
* Transformation to acute myeloid leukemia or ≥20% blasts
* Initiation or dose change of MDS- or anemia-directed therapy (e.g., ESA, luspatercept, hypomethylating agents) within 8 weeks prior to screening
* Red blood cell transfusion \>2 units within 8 weeks prior to enrollment
* Current use of SGLT2 inhibitors or history of serious adverse reaction to SGLT2 inhibitors
* Uncontrolled diabetes mellitus (e.g., HbA1c \>10%) or history of diabetic ketoacidosis
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²
* Active or uncontrolled infection
* Absolute neutrophil count (ANC) \<0.75 ×10⁹/L or platelet count \<50 ×10⁹/L
* Pregnant 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.