Dapagliflozin for Anemia in Lower-Risk Myelodysplastic Syndromes

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeug yun Yoon, MD

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

37 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Seug yun Yoon, MD

Lead sponsor

Soonchunhyang University Hospital

Sponsor institution

Boryung Pharmaceutical Co., Ltd

Collaborator