How SGLT2 inhibitor diabetes medicines affect kidney tissue in diabetic kidney disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who already had a kidney biopsy or kidney surgery as part of their regular care. It studies kidney tissue, blood and urine in people who do or do not take SGLT2 inhibitors.

Age

18 years or older

Sex

All sexes can join.

Disease stage

Kidney function (eGFR) of 10 ml/min/1.73 m2 or higher. Diabetic kidney disease is the main focus, but other groups can join too.

Earlier treatment

Must have had a clinically indicated kidney biopsy, living donor biopsy, or nephrectomy, with non-tumor adjacent tissue available. People who take SGLT2 inhibitors and similar people who do not are both studied.

Main reasons for not taking part

• Cannot give informed consent
• Stored biopsy or surgical tissue is not available for slide preparation
• Local institutional policy does not allow release of H&E slides for research

The registry criteria, word for word

What the trial wants to find out

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 4 groups in the trial

• 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.

  Treatment: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Renin-angiotensin-aldosterone system blockade, Glucagon-like peptide-1 receptor agonists (GLP 1 RA), and Mineralocorticoid Receptor Antagonists(MRAs)

• 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.

  Treatment: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Renin-angiotensin-aldosterone system blockade, Glucagon-like peptide-1 receptor agonists (GLP 1 RA), and Mineralocorticoid Receptor Antagonists(MRAs)

• 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.

  Treatment: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Renin-angiotensin-aldosterone system blockade, Glucagon-like peptide-1 receptor agonists (GLP 1 RA), and Mineralocorticoid Receptor Antagonists(MRAs)

• 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.

  Treatment: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Renin-angiotensin-aldosterone system blockade, Glucagon-like peptide-1 receptor agonists (GLP 1 RA), and Mineralocorticoid Receptor Antagonists(MRAs)