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.

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NCT07444203

Transformative Research in Diabetic Nephropathy 2.0

Recruiting
Not specifiedAges 18+Observational
University of Pennsylvania
~200 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Sodium-glucose cotransporter 2 inhibitors (SGLT2i)Renin-angiotensin-aldosterone system blockadeGlucagon-like peptide-1 receptor agonists (GLP 1 RA)Mineralocorticoid Receptor Antagonists(MRAs)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Kidney Tissue molecular fingerprint
Measured over Baseline enrollment to 18 months.
Diabetic Nephropathies
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
1 sites across 1 states
Pennsylvania1
  • Katalin Susztak, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

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Eligibility criteria

Inclusion

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

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.
  • 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.