Mechanisms Underlying SGLT2i Kidney Effect in DKD Progression

Korábbi kezelés

• Concomitant treatment with steroids or any other immunosuppressive agent
• Drug or alcohol abuse

Más betegség

• Contraindications to MRI including claustrophobia, pregnancy or lactating, cardiac pacemakers, or other MRI-incompatible prostheses, or impossibility to perform MRI
• Any chronic clinical condition (e.g. history of malignancy) other than CKD and related complications that could affect completion of the trial or confound data interpretation
• Non-diabetic CKD: CKD highly suspected to be related with a different renal condition other than Diabetes Mellitus as the cause of CKD (i.e. glomerular disease, tubulo-interstitial nephritis, microangiopathic thrombotic disease, renovascular/ischemic kidney disease, etc)
• Active systemic autoimmune diseases
• Chronic heart failure with New York Heart Association class III-IV at the screening visit

Laborértékek

• Uncontrolled diabetes (glycated hemoglobin (A1C) > 8%; 64 mmol/mol)

Egyéb

• Intention to become pregnant in the following 2 years (female patients)

• male and female subjects aged ≥ 18 years;
• written informed consent prior to any study specific procedures
• type 2 Diabetes Mellitus with DKD
• CKD stage 1 to 3 (eGFR>30 ml/min) with moderate or severe risk of renal disease progression (according to KDIGO 2024 CKD guidelines, G1 and G2 with albuminuria >300 mg/g, G3a with albuminuria >30 mg/g, and G3b independently of albuminuria levels)
• ongoing SGLT2i treatment (e.g. canagliflozin, empagliflozin or dapagliflozin) for at least 1 year and stable RAS inhibitor therapy with ACE inhibitors and/or ARBs (or without RAS inhibitors in patients with specific contraindications for this medication)