Transformative Research in Diabetic Nephropathy 2.0
Sponsored by University of Pennsylvania
About this study
The goal of this observational study is to learn more about kidney health in adults with diabetic kidney disease and other groups. Researchers will study kidney tissue and other samples. They want to learn how sodium-glucose cotransporter-2 (SGLT2) inhibitors, a type of diabetes medicine, may affect the kidneys. People can join only if they are already having a kidney biopsy or kidney surgery as part of their regular medical care. The main questions this study aims to answer are: * Do people who take SGLT2 inhibitors show different biological patterns in kidney tissue than similar people who do not take them? * Are these kidney tissue patterns linked with how kidney health changes over time? Researchers will compare participants who take SGLT2 inhibitors with similar participants who do not take these medicines. Participants will: Let researchers use one stored slide of kidney tissue from their regular care (no extra research biopsy) Give a blood sample and a urine sample Let researchers review medical record information over time
TRIDENT 2.0 is a multicenter observational translational study that characterizes kidney molecular and histopathologic features in relation to exposure to kidney-protective therapies, with a focus on sodium-glucose cotransporter-2 (SGLT2) inhibitors. The study leverages archived clinical kidney pathology material and harmonized clinical data to support integrated molecular-histologic analyses across participating sites. Tissue sources and central repository workflows: Formalin-fixed, paraffin-embedded (FFPE) kidney tissue sections/slides are generated from archived clinical pathology material (including clinically indicated kidney biopsies and available donor or nephrectomy specimens) and transferred under coded identifiers to a central repository for downstream molecular assays and digi…
Where this study is enrolling
- I'm interested
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania
Who can participate
Inclusion criteria
- ✓Age ≥18 years
- ✓eGFR ≥10 ml/min/1.73 m2 based on the 2021 race-free CKD-EPI equation13
- ✓Underwent a clinically indicated kidney biopsy, living donor biopsy, or nephrectomy (non-tumor adjacent tissue available).
- ✓Able and willing to provide informed consent for release of one pathology and clinical data abstraction.
Exclusion criteria
- ✕Inability to provide informed consent.
- ✕Archived biopsy or surgical tissue unavailable for slide preparation.
- ✕Any local institutional policy that prohibits release of H\&E slides for research.
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Trial data sourced from ClinicalTrials.gov.