Recruiting

SGLT2 Inhibitors

Sponsor:

University of Pennsylvania

Code:

NCT07444203

Conditions

Diabetic Nephropathies

Kidney Diseases

Renal Insufficiency, Chronic

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sodium-glucose cotransporter 2 inhibitors (SGLT2i)

Renin-angiotensin-aldosterone system blockade

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

Mineralocorticoid Receptor Antagonists(MRAs)

Study Details

Brief 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

Study ID

NCT07444203

Start date

Nov 12, 2025

Status verified date

Feb, 2026

Completion date

Nov 12, 2028

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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.

Renin-angiotensin-aldosterone system blockade

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

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

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

Mineralocorticoid Receptor Antagonists(MRAs)

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

Primary outcome measure

  • Change in Kidney Tissue molecular fingerprint [ Time Frame: Baseline enrollment to 18 months. ]

Central Contacts and Locations

Central contacts

Gaia Coppock, MD

2673030158Gaia.Coppock@pennmedicine.upenn.edu

Mohammed Al Dulaimee, BS

5853589733mohammed.aldulaimee@pennmedicine.upenn.edu

Locations

Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Gaia Coppock, MD

2673030158Gaia.Coppock@pennmedicine.upenn.edu

Mohammed Al Dulaimee, BS

5853589733mohammed.aldulaimee@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Diabetic nephropathy
  • Chronic kidney disease
  • Diabetic kidney disease
  • Sodium-glucose cotransporter 2 inhibitors
  • Spatial transcriptomics
  • Kidney-protective therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.