Diabetes mellitus is the leading cause of Chronic Kidney Disease, yet only some patients develop Diabetic Kidney Disease (DKD) and follow individual trajectories. Sodium–glucose cotransporter 2 inhibitors (SGLT2i) show strong nephroprotective benefits and are now first-line DKD therapy, but mechanisms driving variable responses remain unclear.
Early identification of patients likely to benefit is essential for personalised care and cost-effective treatment, requiring sensitive biomarkers of progression and therapeutic response.
Renal multiparametric MRI and serum MMP-10/TIMP-1 offer promising insights into kidney pathophysiology and SGLT2i pathways. PERSONALISE-DKD will refine methods, validate biomarkers, and uncover early predictors of SGLT2i nephroprotection.
Investigate SGLT2i nephroprotective mechanisms in DKD rapid and slow progressors
Assess SGLT2i effect on renal microstructure and MMPs-related pathways
Preclinically identify renal mpMRI biomarkers most sensitive to acute and chronic SGLT2i effects in DKD
Identify the optimal biomarker combinations and develop predictive models allowing to monitor disease progression and response to SGLT2i in DKD
Ensure reflection on ethical, legal and social issues, and promote active involvement of patients, citizens and other stakeholders
To develop MRI data sharing guidelines ensuring ethics and confidentiality, and assess patient, health care and ethic professionals.
Title: PhD
Institution: Istituto di Ricerche Farmacologiche Mario Negri IRCCS (IRFMN)
Via Camozzi 3. Postal Code 24020
Ranica (BG) Italy
Title: Dr
Institution: Institution Clínica Universidad de Navarra (UNAV)
Pio XII, 36. Postal Code 31008
Pamplona. Spain
Title: Head of Department, Associate Professor
Institution: Aarhus University (AU)
Palle Juul Jensens Boulevard 99. Postal Code 8200 Aarhus N. Denmark
Title: Prof. DR
Institution: Heidelberg University (UHEI)
Theodor-Kutzer-Ufer 1-3. Postal Code 68167 Mannheim, Germany
Title: PhD
Institution: Siemens SRL
Title: Dr.sc.soc, MSc Bioethics
Institution: University of Latvia (UL)
Elgavas iela 3, Zemgales priekšpilsēta Rīga, LV-1004, Latvia
Title: PhD
Institution: European Kidney Patients Federation (EKPF) (UL)
35 Constancia St. Local 2. Madrid 28002 (Spain)
Lead: IRFMN
Participating:All partners
Task | Title | Timeline | Lead |
T1.1 | Project management | M1–M36 | IRFMN |
T1.2 | Risk management and contingency plan | M1–M36 | IRFMN |
Lead: UHEI
Participating: UHEI, AU
Task | Title | Timeline | Lead |
T2.1 | Experimental design | M1–M12 | UHEI |
T2.2 | Acute effects of SGLT2i: Imaging experiments | M13–M24 | AU |
T2.3 | Chronic renal effects of SGLT2i: Imaging experiments | M13–M24 | UHEI |
T2.4 | Urine and tissue renal kidney damage markers | M13–M24 | AU |
T2.5 | Does renal metabolic MRI predict treatment effects? | M25–M36 | AU |
Lead: IRFMN
Participating: IRFMN, UNAV, AU, UL, EKPF
Task | Title | Timeline | Lead |
T3.1 | Study protocol | M1–M6 | IRFMN |
T3.2 | Study delivery | M7–M30 | IRFMN |
T3.3 | Statistical analysis | M13–M36 | UNAV |
Lead: SIE
Participating: UHEI, UNAV, AU, IRFMN
Task | Title | Timeline | Lead |
T4.1 | Central Database | M1–M36 | SIE |
T4.2 | MRI data quality control and processing | M7–M30 | UHEI |
T4.3 | Image normalisation and Radiomics feature extraction | M13–M30 | UHEI |
T4.4 | DeepReasoner for clinical decision support | M1–M36 | SIE |
Lead: UL
Participating: All partners
Task | Title | Timeline | Lead |
T5.1 | Mapping ELSI challenges | M1–M24 | UL |
T5.2 | Developing informative materials for patients and the general public | M20–M32 | UL |
T5.3 | Developing ethical decision-making support tool | M24–M36 | UL |
T5.4 | Compliance with legal and ethical requirements | M1–M36 | UL |
Lead: UNAV
Participating: All partners
Task | Title | Timeline | Lead |
T6.1 | Dissemination and communication | M1–M36 | UNAV |
T6.2 | Exploitation and IPR protection plan | M13–M36 | SIE |
| Milestone | Month | WP | Means of verification |
|---|---|---|---|
| M.1 Clinical study protocol approved, and 1st patient enrolled | M6 | WP3 | D3.1 |
| M.2 Experimental studies designed and approved | M12 | WP2 | D2.1 |
| M.3 Project website launched | M12 | WP6 | D6.2 |
| M.4 Clinical study enrolment completed | M18 | WP3 | D3.2 |
| M.5 Workshop for mapping of ELSI challenges | M23 | WP5 | D5.1 |
| M.6 Experimental studies completed | M24 | WP2 | D2.2, D2.3, D2.4 |
| M.7 Image data processing pipeline implemented | M24 | WP4 | D4.2, D4.3 |
| M.8 Workshop for development of informative materials | M30 | WP5 | D5.2 |
| M.9 Experimental data analyses completed | M36 | WP2 | D2.5 |
| M.10 Clinical study completed | M36 | WP3 | D3.4 |
| M.11 Clinical data analyses completed | M36 | WP3 | D3.5 |
| M.12 Clinical decision support system implemented | M36 | WP4 | D4.4 |
