RecruitingRecruiting
Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients
NCT06897605 · Mansoura University
In plain English
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Official title
Clinical Study Evaluating the Impact of Dapagliflozin on Erythropoiesis-Stimulating Agent Responsiveness in Anemic Patients With Chronic Kidney Disease
About this study
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
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.
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-04-01
Estimated completion: 2025-10
Last updated: 2025-04-02
Interventions
Drug: Dapagliflozin (DAPA)Drug: Erythropoiesis Stimulating Agent
Primary outcomes
- • Change in Erythropoiesis stimulating agent therapy dose (12 weeks)
Sponsor
Mansoura University · other
Contacts & investigators
ContactBasma M. Sayed Ahmed, M.Sc. · contact · basma_mohamed@mans.edu.eg · +201207753307
InvestigatorNoha O. Mansour, Ph.D. · principal_investigator, Mansoura University
All locations (1)
Urology and Nephrology CenterRecruiting
Al Mansurah, Egypt