Mechanisms Underlying SGLT2i Kidney Effect in DKD Progression

NCT07270198 · tracked via the Priya Life Science Italy tracker

Sponsor

Mario Negri Institute for Pharmacological Research

Phase

Not applicable

Started

2026-02

Last updated

2025-12-08

Condition(s) studied

Diabetic Kidney Disease (DKD)

Investigational drug(s) / intervention(s)

MRI

MRI: Multiparametric non-contrast enhanced renal MRI and biochemical analysis to investigate MMP-related pathways (MMP-10 and TIMP-1 serum levels)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria): * 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) Exclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial): * 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) * Active systemic autoimmune diseases * Concomitant treatment with steroids or any other immunosuppressive agent * Chronic heart failure with New York Heart Association class III-IV at the screening visit * Intention to become pregnant in the following 2 years (female patients) * Drug or alcohol abuse

Primary outcome measure(s)

Estimated glomerular filtration rate (eGFR) — At day 0, at 1 month and at 18 months
EGFR estimation by CKD-EPI and EKFC equations (ml/min)
Matrix metalloproteases (MMPs) and their tissue inhibitors (TIMP) — At day 0, at 1 month and at 18 months
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 — At day 0, at 1 month and at 18 months
Total kidney, cortical and medullary volumes (in mL)
Multiparametric kidney MRI — At day 0, at 1 month and at 18 months
Renal tissue oxygenation obtained by measuring the R2\* relaxation rate (in 1/ms)
Multiparametric kidney MRI — At day 0, at 1 month and at 18 months
Apparent diffusion coefficient (in cm2/s)
Multiparametric kidney MRI — At day 0, at 1 month and at 18 months
Renal tissue perfusion (in mL/100mL/min)
Multiparametric kidney MRI — At day 0, at 1 month and at 18 months
Renal blood flow (in mL/min)
Multiparametric kidney MRI — At day 0, at 1 month and at 18 months
T1 and T2 relaxation times (in ms)

Trial sites (1)

Facility	City	Region	Status
Clinical Research Centre for Rare Diseases Aldo e Cele Daccò	Ranica	BG

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07270198 on ClinicalTrials.gov ↗ ← All trials in Italy