Dapagliflozin for Anemia in Lower-Risk Myelodysplastic Syndromes

Sponsor
Seug yun Yoon, MD
Study ID
NCT07516847
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anemia
  • Myelodysplastic Syndromes (MDS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Participants receive dapagliflozin 10 mg orally once daily for 24 weeks.

Primary Outcome Measure

Hemoglobin Response Rate [ Time Frame: Within 24 weeks ]

Central Contacts

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