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NCT Number: NCT06820567

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

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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Key information

About this study

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.

Who can participate

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

Treatment and study plan

Dapagliflozin (DAPA)

Drug

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

Placebo

Drug

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

Primary outcomes

  1. GFR in CKD patients

    Time frame: 6 months

    Measure eGFR using ckd epi equation to detect the effect of dapagliflozin in improvement of GFR in CKD patients

Study contacts

Contact information is provided by the study sponsor or research team.

Mai Mostafa, MD

CONTACT

[email protected]

+201223971678

zeinab khodary, master

CONTACT

[email protected]

+201500009366

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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