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

Phase 3

Not yet recruiting

• Conditions: Diabetes Type 2; Chronic Kidney Diseases
• Interventions: Drug: Dapagliflozin (DAPA); Drug: Placebo

• Registration Number: NCT06820567
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Eligible participants were aged >18 years and diagnosed with Type 2 diabetes participants we required to have urinary albumin-creatinine ratio (UACR ) of 30_3500 mg /g ,eGFR of 20_ 80 ml/min/ 1.73 m , and HbA1c of 7.0 _ 11.0 % at screening

Exclusion Criteria

type 1 diabetes, non-diabetes kidney disease and patient with HB < 9

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Dapagliflozin (DAPA)	type 2 diabetic patients with chronic kidney diseases will recive dapagliflozin
Group B	Placebo	type 2 diabetic patients with chronic kidney diseases will recive placebo

Primary Outcome Measures

Name	Time	Method
GFR in CKD patients	6 months	Measure eGFR using ckd epi equation to detect the effect of dapagliflozin in improvement of GFR in CKD patients