Transformative Research in Diabetic Nephropathy 2.0

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07444203
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sodium-glucose cotransporter 2 inhibitors (SGLT2i) — DRUG
    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 — DRUG
    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) — DRUG
    Standard-of-care exposure documented from medication history for observational comparisons.
  • Mineralocorticoid Receptor Antagonists(MRAs) — DRUG
    Standard-of-care exposure documented from medication history for observational comparisons.

Study Details

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

Key Dates

Start date
Nov 12, 2025
Status verified
Feb 2026
Primary completion
May 30, 2027
Completion
Nov 12, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104
Gaia Coppock, MD
[email protected]
2673030158
Mohammed Al Dulaimee, BS
[email protected]
5853589733

Find similar trials in Philadelphia, PA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Penn Presbyterian Medical Center· Philadelphia, PA

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