Transformative 2.0 for diabetic kidney disease
Official title: Transformative Research in Diabetic Nephropathy 2.0: A Proof of Principle Study of SGLT2 Inhibitors (TRIDENT 2.0)
Run by University of Pennsylvania · NCT07444203 · Data updated 2026-11-12
This project will try to see if adults with diabetic kidney disease who take SGLT2 diabetes medicines have different biological patterns in archived kidney tissue than similar people who do not take these medicines.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | November 12, 2025 |
| Main results expected | May 30, 2027 |
| Study ends | November 12, 2028 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT07444203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with diabetic kidney disease or related kidney conditions who are undergoing or have archived clinically indicated kidney biopsy, living-donor biopsy, or nephrectomy and can consent to release one pathology slide and provide clinical data and blood/urine samples are ideal candidates.
✕Probably not a fit
People who are not having a clinically indicated biopsy or nephrectomy, cannot consent, or whose archived tissue slides are unavailable or restricted by local policy are not likely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
TRIDENT 2.0 is a multicenter observational translational effort that uses archived clinical kidney biopsy and surgical tissue to map molecular and histologic features, with a focus on exposure to SGLT2 inhibitors and other kidney-protective therapies. Researchers will transfer one coded slide of formalin-fixed, paraffin-embedded kidney tissue to a central repository and perform spatial transcriptomics and other molecular assays while preserving tissue architecture. Harmonized clinical data, blood and urine samples, and standardized quality-control pipelines will be integrated to relate tissue-level signatures to medication exposure and longitudinal kidney outcomes. The study compares participants who have documented SGLT2 inhibitor exposure with matched participants who do not, without requiring any additional research biopsy.
Why it matters
Potential benefit: If successful, this work could identify tissue-level signatures linked to SGLT2 use that help explain how these drugs protect kidneys and guide future targeted therapies or biomarkers.
How similar studies have gone: Large randomized trials have shown SGLT2 inhibitors protect kidney function, but applying spatial transcriptomics to link drug exposure to specific tissue signatures is a novel translational approach with limited prior large-scale data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Katalin Susztak, MD, PhD — University of Pennsylvania
- Study coordinator: Gaia Coppock, MD
- Email: Gaia.Coppock@pennmedicine.upenn.edu
- Phone: 2673030158
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.