NCT07270198Not yet recruiting
Mechanisms Underlying SGLT2i Kidney Effect in DKD Progression
Longitudinal Multicentre Clinical Study to Explore the Mechanisms Underlying Kidney Effect of SGLT2i in Diabetic Kidney Disease Patients at Risk of Disease Progression by Multiparametric Renal MRI and Biochemical Markers
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- Feb 2026
- Primary completion date
- Aug 2027
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Diseases
- Chronic kidney disease
- NCT number
- NCT07270198
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Feb 2026 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant treatment with steroids or any other immunosuppressive agent
- Drug or alcohol abuse
Other illness
- 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
Lab values
- Uncontrolled diabetes (glycated hemoglobin (A1C) \> 8%; 64 mmol/mol)
Other
- Intention to become pregnant in the following 2 years (female patients)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Centre for Rare Diseases Aldo e Cele Daccò Coordinator of this site? Confirm its status | Ranica | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.