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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Pennsylvania
Penn Presbyterian Medical Center
RECRUITING
Philadelphia
Contact Information
Primary
Gaia Coppock, MD
Gaia.Coppock@pennmedicine.upenn.edu
2673030158
Backup
Mohammed Al Dulaimee, BS
mohammed.aldulaimee@pennmedicine.upenn.edu
5853589733
Time Frame
Start Date: 2025-11-12
Estimated Completion Date: 2028-11-12
Participants
Target number of participants: 200
Treatments
Biopsy-confirmed Diabetic Kidney Disease Cohort
Adults with diabetic kidney disease confirmed by a clinically indicated kidney biopsy. This cohort is used to evaluate kidney molecular and histopathologic features in relation to medication exposure history.~Interventions/exposures of interest (observational): Primary exposure is sodium-glucose cotransporter 2 inhibitors; additional therapy exposures of interest include renin-angiotensin-aldosterone system blockade, glucagon-like peptide-1 receptor agonists, mineralocorticoid receptor antagonists, and other therapies.
Disease Control Kidney Disease Cohort
Adults with other forms of kidney disease (non-DKD), included as disease controls for cross-disease comparisons of molecular and histologic patterns.~Interventions/exposures of interest (observational): Medication exposure history is captured to support comparisons across therapy classes, including SGLT2 inhibitors and other disease-modifying therapies.
Living Kidney Donor Cohort
Living kidney donors with available donor biopsy tissue, included as a comparator group to provide reference kidney tissue profiles.~Interventions/exposures of interest (observational): Medication exposure history (including kidney-protective therapies where applicable) may be used in descriptive and comparative analyses; donors primarily serve as a reference/control tissue cohort.
Nephrectomy Control Cohort
Adults undergoing nephrectomy with non-tumor, adjacent normal kidney tissue available, included as a control/reference tissue cohort.~Interventions/exposures of interest (observational): Medication exposure history (including SGLT2 inhibitors and other kidney-protective therapies) may be incorporated in comparative analyses across cohorts.
Sponsors
Collaborators: Genentech, Inc., Boehringer Ingelheim, Regeneron Pharmaceuticals, AstraZeneca, Novo Nordisk A/S, GlaxoSmithKline
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov