NCT07516847Not yet recruitingPhase 2
Dapagliflozin for Anemia in Lower-Risk Myelodysplastic Syndromes
A Phase II, Prospective, Open-Label Study to Evaluate the Efficacy and Safety of Dapagliflozin for Anemia in Patients With Lower-Risk Myelodysplastic Syndromes
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Seug yun Yoon, MD
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT07516847
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 37
- From 1 Sept 2026 to the primary completion date, 31 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Current use of SGLT2 inhibitors or history of serious adverse reaction to SGLT2 inhibitors
- Active or uncontrolled infection
- Any condition that, in the investigator's judgment, would make participation inappropriate
Lab values
- Uncontrolled diabetes mellitus (e.g., HbA1c \>10%) or history of diabetic ketoacidosis
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²
- Absolute neutrophil count (ANC) \<0.75 ×10⁹/L or platelet count \<50 ×10⁹/L
Other
- IPSS-R intermediate-high or high-risk MDS
- Transformation to acute myeloid leukemia or ≥20% blasts
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.