Dapagliflozin (DAPA)
Drugpatient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients
NCT Number: NCT06820567
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Phase 3
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
patient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients
type 2 diabetic patients with chronic kidney diseases will recive placebo for 24 weeks
Time frame: 6 months
Measure eGFR using ckd epi equation to detect the effect of dapagliflozin in improvement of GFR in CKD patients
Contact information is provided by the study sponsor or research team.
Mai Mostafa, MD
CONTACT
zeinab khodary, master
CONTACT
Assiut University
Other
English Title of Research Project: Effects of Dapagliflozin on Inflammatory Markers, Erythropoiesis and Iron Metabolism in Patients With Type 2 Diabetes and CKD
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