Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

Phase 2RecruitingNCT06897605

Mansoura University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria 1. Adults aged ≥ 18 years with CKD stage III or IV. 2. Patients with anemia of CKD and a hemoglobin level \< 11.5 g/dL 3. Patients are receiving erythropoiesis-stimulating agent therapy. Exclusion criteria 1. Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes. 2. Patients with severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma. 3. Patients with acute heart failure, acute myocardial infarction, or stroke occurring within 6 months before enrollment in the trial. 4. Patients with current malignancies or a history of malignancy within the past 2 years. 5. Diagnosed with pure red cell aplasia. 6. Patients with severe gastrointestinal bleeding. 7. Pregnant or lactating females.

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.