This is a multicentre and multi-national non-pharmacological, uncontrolled interventional study conducted in a clinical practice setting in DKD patients with CKD stages 1 to 3 with moderate or severe risk of renal function decline in chronic treatment with SGLT2i.
The main aim of the study is to assess the independent role of baseline individual mpMRI markers (hemodynamic, oxygenation, microstructure, perfusion, and fat fraction) and biochemical markers of MMP-related pathways (MMP-10 and TIMP-1) in the prediction of chronic eGFR decline in the above mentioned patients who are on chronic SGLT2i therapy.
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)
Uncontrolled diabetes (glycated hemoglobin (A1C) > 8%; 64 mmol/mol)
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)
Single group
MRI
Procedure/SurgeryMultiparametric non-contrast enhanced renal MRI and biochemical analysis to investigate MMP-related pathways (MMP-10 and TIMP-1 serum levels)
Estimated glomerular filtration rate (eGFR)
EGFR estimation by CKD-EPI and EKFC equations (ml/min)
Matrix metalloproteases (MMPs) and their tissue inhibitors (TIMP)
Serum levels of MMP-10 and TIMP-1 will be assessed in blood samples by commercial ELISA kits, according to the manufacturer's instructions (pg/ml)
Multiparametric kidney MRI
Total kidney, cortical and medullary volumes (in mL)
Multiparametric kidney MRI
Renal tissue oxygenation obtained by measuring the R2\* relaxation rate (in 1/ms)
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