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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-05-01

Brief Summary

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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.

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Detailed Description

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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

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Chronic Kidney Diseases Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

type 2 diabetic patients with chronic kidney diseases will recive dapagliflozin

Group Type ACTIVE_COMPARATOR

Dapagliflozin (DAPA)

Intervention Type DRUG

patient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients

Group B

type 2 diabetic patients with chronic kidney diseases will recive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

type 2 diabetic patients with chronic kidney diseases will recive placebo for 24 weeks

Interventions

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Dapagliflozin (DAPA)

patient will recive dapagliflozin for 24 week to improvement of eGFR on CKD patients

Intervention Type DRUG

Placebo

type 2 diabetic patients with chronic kidney diseases will recive placebo for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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