Chronic Kidney Disease(CKD), Anemia, Kidney Disease, Chronic
Conditions
Brief summary
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.
Interventions
Dapagliflizin 10 mg tablets once daily for 12 weeks
Erythropoiesis stimulating agent (ESA) therapy
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Erythropoiesis stimulating agent therapy dose | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hemoglobin level | 12 weeks | Difference between two groups in hemoglobin level in g/dL at the end of the study. |
Countries
Egypt
Contacts
Primary ContactBasma M. Sayed Ahmed, M.Sc.
Outcome results
None listed