RecruitingNCT07444203

Transformative Research in Diabetic Nephropathy 2.0

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

Sponsor

University of Pennsylvania

Enrollment

200 participants

Start Date

Nov 12, 2025

Study Type

OBSERVATIONAL

Conditions

Diabetes Mellitus, Type 2 Kidney Diseases Diabetic Nephropathies Renal Insufficiency, Chronic

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (TRIDENT 2.0) is collecting kidney tissue samples from people who have had a kidney biopsy or kidney surgery to better understand diabetic kidney disease (also called diabetic nephropathy) — one of the most common complications of diabetes that leads to kidney failure. Researchers will use the tissue to study the disease at a molecular level. **You may be eligible if...** - You are 18 or older - Your kidney function is at least minimally preserved (eGFR of 10 or above) - You have undergone or are undergoing a clinically indicated kidney biopsy, living donor kidney biopsy, or kidney removal where non-tumor tissue is available - You are willing and able to consent to release of one tissue slide and clinical data **You may NOT be eligible if...** - You are unable to provide informed consent - Archived tissue from your biopsy or surgery is not available - Your institution has policies that prevent release of tissue slides for research purposes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSodium-glucose cotransporter 2 inhibitors (SGLT2i)

Standard-of-care exposure to sodium-glucose cotransporter 2 inhibitors documented from medication history. Participants are not assigned therapy. Exposure status is used for observational comparisons of kidney tissue molecular and histopathologic features.

DRUGRenin-angiotensin-aldosterone system blockade

Standard-of-care exposure to renin-angiotensin-aldosterone system blockade documented from medication history for observational comparisons.

DRUGGlucagon-like peptide-1 receptor agonists (GLP 1 RA)

Standard-of-care exposure documented from medication history for observational comparisons.

DRUGMineralocorticoid Receptor Antagonists(MRAs)

Standard-of-care exposure documented from medication history for observational comparisons.

Locations(1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

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