Transformative Research in Diabetic Nephropathy 2.0

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

Conditions

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

Interventions

DRUG

Sodium-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.

DRUG

Renin-angiotensin-aldosterone system blockade

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

DRUG

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

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

DRUG

Mineralocorticoid Receptor Antagonists(MRAs)

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

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Boehringer Ingelheim

  collaborator INDUSTRY

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• Novo Nordisk A/S

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• Genentech, Inc.

  collaborator INDUSTRY

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Katalin Susztak, MD, PhD · University of Pennsylvania

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-11-12

Primary Completion

2027-05-30

Completion

2028-11-12

Countries

• United States

Study Locations