Transformative Research in Diabetic Nephropathy 2.0

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

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

200 Participants
are divided into 4 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