Health TrialsbyHealthPanel

Dapagliflozin for Anemia in Lower-Risk Myelodysplastic Syndromes

ConditionsMyelodysplastic Syndromes (MDS)Anemia
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Dapagliflozin (10mg Tab)

    Drug

    Dapagliflozin 10 mg administered orally once daily for 24 weeks.

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: DapagliflozinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hemoglobin Response Rate

Proportion of patients achieving a hemoglobin increase of ≥1.0 g/dL from baseline, sustained for at least 8 weeks, in the absence of red blood cell transfusion.

Time frame
Within 24 weeks

Secondary outcomes

1

Change in Hemoglobin Level

Mean change in hemoglobin level from baseline during the study period.

Time frame
Up to 24 weeks
2

Proportion of Patients With Hemoglobin Increase ≥1.5 g/dL

Proportion of patients achieving a hemoglobin increase of ≥1.5 g/dL from baseline.

Time frame
Up to 24 weeks
3

Change in Red Blood Cell Transfusion Requirement

Change in red blood cell transfusion requirement compared to baseline.

Time frame
Up to 24 weeks
4

Duration of Hemoglobin Response

Duration from first documented hemoglobin response to loss of response.

Time frame
Up to 24 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seug yun Yoon, MD

Lead sponsor

Soonchunhyang University Hospital

Sponsor institution

Boryung Pharmaceutical Co., Ltd

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: