Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

ConditionsChronic Kidney Disease(CKD)Anemia, Kidney Disease, Chronic

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMansoura University

About this trial

Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, primarily used in the management of type 2 diabetes mellitus. Emerging research suggests that SGLT2 inhibitors may offer additional benefits, including reducing the risk of cardiovascular events and renal complications. Post hoc analyses of previous clinical trials have shown that patients treated with SGLT2 inhibitors exhibited higher levels of hemoglobin and hematocrit compared to those in the control group. These findings suggest that dapagliflozin's ability to elevate hemoglobin levels could potentially be utilized for the treatment of anemia in patients with chronic kidney disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥ 18 years with CKD stage III or IV.

Patients with anemia of CKD and a hemoglobin level < 11.5 g/dL

Patients are receiving erythropoiesis-stimulating agent therapy.

Disqualifiers

Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.

Patients with severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma.

Patients with acute heart failure, acute myocardial infarction, or stroke occurring within 6 months before enrollment in the trial.

Patients with current malignancies or a history of malignancy within the past 2 years.

Trial design

Design model

Parallel

Treatments tested in this trial

Dapagliflozin (DAPA)
Drug
Dapagliflizin 10 mg tablets once daily for 12 weeks
Erythropoiesis Stimulating Agent
Drug
Erythropoiesis stimulating agent (ESA) therapy

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Dapagliflozin + ESA groupExperimental treatment 2 interventions

Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

Change in Erythropoiesis stimulating agent therapy dose

Difference between two groups in comulative dose of erythropoiesis stimulating agent therapy (E.S.A) in international unit (I.U) at the end of the study.

Time frame

12 weeks

Secondary outcomes

Changes in hemoglobin level

Difference between two groups in hemoglobin level in g/dL at the end of the study.

Time frame

12 weeks

Sponsors and contacts

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Mansoura University

Lead sponsor

Source ClinicalTrials.gov

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