About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sodium-glucose cotransporter 2 inhibitors (SGLT2i)
- Renin-angiotensin-aldosterone system blockade
- Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
- Mineralocorticoid Receptor Antagonists(MRAs)
Treatment groups
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
GlaxoSmithKline
Collaborator
Boehringer Ingelheim
Collaborator
Regeneron Pharmaceuticals
Collaborator
Novo Nordisk A/S
Collaborator
AstraZeneca
Collaborator
Genentech, Inc.
Collaborator