Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

Phase 2

Recruiting

• Conditions: Chronic Kidney Disease(CKD); Anemia, Kidney Disease, Chronic
• Interventions: Drug: Dapagliflozin (DAPA); Drug: Erythropoiesis Stimulating Agent

• Registration Number: NCT06897605
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study Start: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin + ESA group	Dapagliflozin (DAPA)	patients will receive dapagliflozin 10 mg tablet once daily in addition to standard care therapy of erythropoiesis-stimulating agents (ESA)
Dapagliflozin + ESA group	Erythropoiesis Stimulating Agent	patients will receive dapagliflozin 10 mg tablet once daily in addition to standard care therapy of erythropoiesis-stimulating agents (ESA)
Control group	Erythropoiesis Stimulating Agent	patients will receive standard care therapy of erythropoiesis-stimulating agents (ESA)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in hemoglobin level	12 weeks	Difference between two groups in hemoglobin level in g/dL at the end of the study.

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Egypt