Transformative Research in Diabetic Nephropathy 2.0 A Proof of Principle Study of SGLT2 Inhibitors TRIDENT 2.0

What this Trial Is About

Researchers are investigating kidney health in adults with diabetic kidney disease and other kidney conditions to understand how sodium-glucose cotransporter-2 SGLT2 inhibitors, a type of diabetes medicine, may affect the kidneys. This observational study aims to compare kidney tissue patterns between people who take SGLT2 inhibitors and those who do not, and to see how these patterns relate to changes in kidney health over time. The study uses archived kidney biopsy and surgery tissue samples along with clinical data from multiple centers. The study collects formalin-fixed, paraffin-embedded kidney tissue slides from clinical biopsies or surgeries and analyzes them using advanced molecular and digital pathology methods. These include spatial transcriptomics to map molecular features while keeping tissue structure intact and standardized lesion scoring by expert pathologists. Medication histories, including exposure to SGLT2 inhibitors and other kidney-protective drugs, are recorded to support comparisons. Participants fall into groups including those with diabetic kidney disease, other kidney diseases, living kidney donors, and nephrectomy patients with normal tissue. Participants contribute one stored kidney tissue slide from their regular care, along with blood and urine samples. Researchers will review medical records over time to track clinical outcomes and correlate them with molecular and histologic findings. Outcomes measured include changes in kidney tissue molecular fingerprint, kidney function eGFR, urine protein levels, and histopathological features. The study may follow participants data for up to three years to observe long-term associations with kidney health and medication exposure.

Transformative Research in Diabetic Nephropathy 2.0