Mechanisms Underlying SGLT2i Kidney Effect in DKD Progression
Italy100 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Estimated glomerular filtration rate (eGFR)
Timeframe: At day 0, at 1 month and at 18 months
2
Matrix metalloproteases (MMPs) and their tissue inhibitors (TIMP)
Timeframe: At day 0, at 1 month and at 18 months
3
Multiparametric kidney MRI
Timeframe: At day 0, at 1 month and at 18 months
4
Multiparametric kidney MRI
Timeframe: At day 0, at 1 month and at 18 months
5
Multiparametric kidney MRI
Timeframe: At day 0, at 1 month and at 18 months
6
Multiparametric kidney MRI
Timeframe: At day 0, at 1 month and at 18 months
7
Multiparametric kidney MRI
Timeframe: At day 0, at 1 month and at 18 months
8
Trial details
NCT IDNCT07270198
SponsorMario Negri Institute for Pharmacological Research