Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

Mansoura University

Status and phase: Enrolling; Phase 2

Conditions: Anemia, Kidney Disease, Chronic; Chronic Kidney Disease(CKD)

Treatments: Drug: Dapagliflozin (DAPA); Drug: Erythropoiesis Stimulating Agent

Study type: Interventional

Funder types: Other

Identifiers

NCT06897605

2024-117'1

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Dapagliflozin + ESA group

Experimental group

Description:

patients will receive dapagliflozin 10 mg tablet once daily in addition to standard care therapy of erythropoiesis-stimulating agents (ESA)

Treatment:

Drug: Erythropoiesis Stimulating Agent

Drug: Dapagliflozin (DAPA)

Control group

Other group

Description:

patients will receive standard care therapy of erythropoiesis-stimulating agents (ESA)

Treatment:

Drug: Erythropoiesis Stimulating Agent