Observational Study of Kidney Health in Diabetic Nephropathy
This observational study, called TRIDENT 2.0, aims to understand how different diabetes medications affect kidney health in people with diabetic kidney disease. Researchers will look at kidney tissue and other samples from adults aged 18 and older. They are particularly interested in how sodium-glucose cotransporter 2 inhibitors (SGLT2i), renin-angiotensin-aldosterone system blockade, glucagon-like peptide-1 receptor agonists (GLP 1 RA), and mineralocorticoid receptor antagonists (MRAs) impact the kidneys. You can join if you are already having a kidney biopsy or kidney surgery as part of your regular medical care and your eGFR (a measure of kidney function) is at least 10 ml/min/1.73 m2. The main goal is to see if people taking SGLT2 inhibitors show different patterns in their kidney tissue and if these patterns are linked to how kidney health changes over time. The study will look at changes in kidney tissue molecular fingerprints over 18 months.
- Study design
- This is an observational study with a planned enrollment of 200 participants. Participants are not assigned therapy; their existing medication history is used for comparisons.
- What's involved
- You would need to provide informed consent for the release of your pathology and clinical data. This study uses kidney tissue from a clinically indicated kidney biopsy, living donor biopsy, or nephrectomy you are already undergoing.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure changes in kidney tissue molecular fingerprints from baseline enrollment to 18 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Transformative Research in Diabetic Nephropathy 2.0
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Katalin Susztak, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Kidney Tissue molecular fingerprintBaseline enrollment to 18 months.
Change/differences in kidney tissue molecular "fingerprint" (molecular pathways / spatial gene expression signatures derived from archived kidney tissue) comparing participants exposed to sodium-glucose cotransporter 2 inhibitors versus controls and participants on other therapies. Tissue profiling includes single-cell spatial transcriptomics with differential expression and pathway analyses stratified by therapy exposure.