NCT06820567

Effects Dapagliflozin on Inflammatory Markers Erythropoiesis and Iron Metabolism in Patients With Type 2 Diabetes and CKD

English Title of Research Project: Effects of Dapagliflozin on Inflammatory Markers, Erythropoiesis and Iron Metabolism in Patients With Type 2 Diabetes and CKD

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

the effect of Dapagliflozin on erythropoiesis, iron metabolism and inflammatory markers in CKD with Type 2 DM-Compare between effect of placebo and dapagliflozin on erythropoiesis, iron metabolism and inflammation markers in CKD with Type 2 DM.

Detailed description

Type 2 diabetes is considered an important cause of chronic kidney diseases (CKD) ,in those patients the inflammation is the most assumed cause of the decrease in erythropoietin synthesis and abnormal iron metabolism leading to anemia (1\_3). Sodium glucose cotransporter 2 (SGLT2) inhibitors like Dapagliflozin are oral medications approved for type 2 diabetes. interestingly, during recent years, they have been promisingly considered as anew medications for cardiovascular and kidney diseases (4). Researchers suggested that SGLT 2 inhibitors play an important role in reducing CKD progression and renal failure with patients with type 2 DM based on the clinical outcomes and laboratory findings rather than completely understood mechanism (5\_8) Investigators reported that reduced transferrin saturation (TSAT), ferritin and hepcidin and circulating and urinary inflammatory mediators, including monocyte chemoattractant protein-1 (MCP -1 ) and interleukin-6 (IL-6) transiently increased EPO suggesting SGLT 2 inhibition may help iron utilization and promote erythropoiesis decreasing anemia ( 9-14) Here we are studying the effects of the SGLT 2 inhibitor Dapagliflozin regarding markers of erythropoiesis, iron metabolism and inflammation in patients with Type 2 DM and CKD.

Conditions

• Chronic Kidney Diseases
• Diabetes Type 2

Interventions

Type	Name	Description
DRUG	Dapagliflozin (DAPA)	patient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients
DRUG	Placebo	type 2 diabetic patients with chronic kidney diseases will recive placebo for 24 weeks

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-01
• Completion: 2027-05-01
• First posted: 2025-02-11
• Last updated: 2025-02-11

Regulatory

• FDA-regulated drug study