About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dapagliflozin (10mg Tab)
Treatment groups
Locations
Sponsors and collaborators
Seug yun Yoon, MD
Lead sponsor
Soonchunhyang University Hospital
Sponsor institution
Boryung Pharmaceutical Co., Ltd
Collaborator