Diabetic NephropathiesTRIDENT 2NCT07444203
Transformative Research in Diabetic Nephropathy 2.0
An observational study of Diabetic Nephropathies and Kidney Diseases, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathies, Kidney Diseases, Renal Insufficiency, Chronic
- What is being tested?
- Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Renin-angiotensin-aldosterone system blockade and Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 12 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: TRIDENT 2.0 will enroll approximately 200 participants across multiple sites. Eligible participants include: * Patients with diabetic kidney disease (DKD) confirmed by clinically indicated biopsy. * Patients with other kidney diseases (disease controls). * Living kidney donors (donor biopsy tissue). * Patients undergoing nephrectomy (non-tumor, adjacent normal tissue when available). All participants must provide informed consent for release of one H\&E slide from their clinical biopsy or surgical specimen and for abstraction of relevant clinical data.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Gaia Coppock, MD, 2673030158, Gaia.Coppock@pennmedicine.upenn.edu
Mohammed Al Dulaimee, BS, 5853589733, mohammed.aldulaimee@pennmedicine.upenn.edu
About this study
Official title: Transformative Research in Diabetic Nephropathy 2.0: A Proof of Principle Study of SGLT2 Inhibitors (TRIDENT 2.0)
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:
Read more
- 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
Read the detailed description
TRIDENT 2.0 is a multicenter observational translational study that characterizes kidney molecular and histopathologic features in relation to exposure to kidney-protective therapies, with a focus on sodium-glucose cotransporter-2 (SGLT2) inhibitors. The study leverages archived clinical kidney pathology material and harmonized clinical data to support integrated molecular-histologic analyses across participating sites.
Tissue sources and central repository workflows:
Formalin-fixed, paraffin-embedded (FFPE) kidney tissue sections/slides are generated from archived clinical pathology material (including clinically indicated kidney biopsies and available donor or nephrectomy specimens) and transferred under coded identifiers to a central repository for downstream molecular assays and digital pathology.
Spatial transcriptomics and molecular profiling:
Spatially resolved transcriptomic methods are used to generate high-resolution molecular maps while preserving tissue architecture. FFPE (or fresh-frozen, when available) sections may be processed using commercially available spatial transcriptomics platforms (e.g., 10x Genomics Visium, NanoString CosMx, Xenium) or updated technologies implemented under study governance. Standard quality control procedures evaluate tissue integrity, RNA quality, capture efficiency, and resolution of major kidney compartments and cell types. Sequencing is performed on Illumina platforms with platform-appropriate depth, followed by preprocessing using platform-specific pipelines and downstream analysis in R/Python workflows (e.g., Seurat or equivalent) with normalization and batch correction as needed. Planned analyses include identification of cell-type and sub-cell-type signatures in spatial context, mapping of injury patterns (e.g., fibrosis/inflammation/vascular remodeling), and comparative molecular profiling across disease categories and therapy exposure groups with adjustment for relevant covariates.
Digital pathology and centralized histopathology review:
Digitized clinical stains and available diagnostic images are used for centralized review and standardized lesion scoring by renal pathologists. When applicable, diabetic kidney disease (DKD) is classified using established renal pathology criteria. Specimen adequacy metrics are used to guide analytic inclusion and sensitivity analyses.
Linked clinical data (high level):
Clinical data are harmonized across sites to support clinicopathologic and molecular integration, including medication exposure history and relevant laboratory and diagnostic variables. Longitudinal clinical information is used to contextualize molecular and histologic findings for downstream modeling.
Statistical and integrative analytic approach:
Analytic methods include differential expression and pathway analyses with appropriate multiple-testing control and covariate adjustment. Integrative modeling may combine molecular, histologic, and clinical domains using dimension reduction and regularized approaches to derive molecular signatures associated with disease state and therapy exposure.
- Conditions
- Diabetic Nephropathies, Kidney Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
- Being tested
- Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Renin-angiotensin-aldosterone system blockade, Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Mineralocorticoid Receptor Antagonists(MRAs)
- Keywords
- Diabetic nephropathy, Chronic kidney disease, Diabetic kidney disease, Sodium-glucose cotransporter 2 inhibitors, Spatial transcriptomics, Kidney-protective therapy
- Medical subject headings
- Diabetic Nephropathies, Kidney Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium-glucose cotransporter 2 inhibitors (SGLT2i)Drug
Also called SGLT2 inhibitors
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 blockadeDrug
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
Also called GLP-1 receptor agonists
Standard-of-care exposure documented from medication history for observational comparisons.
Mineralocorticoid Receptor Antagonists(MRAs)Drug
Also called MRAs
Standard-of-care exposure documented from medication history for observational comparisons.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i); Drug: Renin-angiotensin-aldosterone system blockade; Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA); Drug: 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. Receives: Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i); Drug: Renin-angiotensin-aldosterone system blockade; Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA); Drug: 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. Receives: Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i); Drug: Renin-angiotensin-aldosterone system blockade; Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA); Drug: 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. Receives: Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i); Drug: Renin-angiotensin-aldosterone system blockade; Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA); Drug: Mineralocorticoid Receptor Antagonists(MRAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kidney Tissue molecular fingerprint
Change/differences in kidney tissue molecular "fingerprint" (molecular pathways / spatial gene expression signatures derived from archived kidney tissue) comparing participants exposed to sodium-glucose cotransporter 2 inhibitors versus controls and participants on other therapies. Tissue profiling includes single-cell spatial transcriptomics with differential expression and pathway analyses stratified by therapy exposure.
Measured: Baseline enrollment to 18 months.
Secondary outcomes (6)
Change in estimated glomerular filtration rate (eGFR)
Change in eGFR calculated using the 2021 race-free CKD-EPI equation.
Measured: Baseline to 18 months
Change in urine protein/creatinine ratio
Change in urine protein/creatinine ratio over follow-up.
Measured: Baseline to 6 months.
Descriptive histopathology features and spatial gene expression patterns across cohorts
Descriptive histopathological features (fibrosis, sclerosis, inflammation, vascular changes) and spatial gene expression patterns evaluated across diabetic kidney disease, disease controls, donor, and nephrectomy cohorts.
Measured: At enrollment/baseline (Single assessment on the archived clinical specimen slide)
Associations between histopathological features and clinical outcomes
Associations between histopathological features and clinical outcomes including eGFR slope, proteinuria, kidney failure, and transplant.
Measured: Up to 3 years (longitudinal outcome abstraction, including dialysis/transplant/kidney failure/mortality as captured).
Associations between histopathological features and prior medication exposures
Associations between histopathological features and prior medication exposures, including SGLT2 inhibitors, renin-angiotensin-aldosterone system blockade, glucagon-like peptide-1 receptor agonists, mineralocorticoid receptor antagonists, and other therapies.
Measured: Baseline (prior/current medication exposure history at enrollment).
Feasibility metrics
Accrual rate by cohort, proportion of slides successfully retrieved, and slide quality metrics.
Measured: During study accrual and specimen acquisition (up to 3 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start12 Nov 2025
- Primary completion30 May 2027 (estimated)
- Study completion12 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Boehringer Ingelheim, Regeneron Pharmaceuticals, Novo Nordisk A/S, AstraZeneca, Genentech, Inc.
- Responsible party
- Principal investigator, Katalin Susztak, University of Pennsylvania
- Investigators
- Katalin Susztak, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444203
- Sponsor's protocol ID
- 849580
- Acronym
- TRIDENT 2
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transformative Research in Diabetic Nephropathy 2.0: A Proof of Principle Study of SGLT2 Inhibitors (TRIDENT 2.0)
- ClinicalTrials.gov ID
- NCT07444203
- Acronym / sponsor ID
- TRIDENT 2 / 849580
- Conditions
- Diabetic Nephropathies, Kidney Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
- Keywords
- Diabetic nephropathy, Chronic kidney disease, Diabetic kidney disease, Sodium-glucose cotransporter 2 inhibitors, Spatial transcriptomics, Kidney-protective therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Boehringer Ingelheim, Regeneron Pharmaceuticals, Novo Nordisk A/S, AstraZeneca, Genentech, Inc.
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 12 Nov 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
TRIDENT 2.0 is a multicenter observational translational study that characterizes kidney molecular and histopathologic features in relation to exposure to kidney-protective therapies, with a focus on sodium-glucose cotransporter-2 (SGLT2) inhibitors. The study leverages archived clinical kidney pathology material and harmonized clinical data to support integrated molecular-histologic analyses across participating sites.
Tissue sources and central repository workflows:
Formalin-fixed, paraffin-embedded (FFPE) kidney tissue sections/slides are generated from archived clinical pathology material (including clinically indicated kidney biopsies and available donor or nephrectomy specimens) and transferred under coded identifiers to a central repository for downstream molecular assays and digital pathology.
Spatial transcriptomics and molecular profiling:
Spatially resolved transcriptomic methods are used to generate high-resolution molecular maps while preserving tissue architecture. FFPE (or fresh-frozen, when available) sections may be processed using commercially available spatial transcriptomics platforms (e.g., 10x Genomics Visium, NanoString CosMx, Xenium) or updated technologies implemented under study governance. Standard quality control procedures evaluate tissue integrity, RNA quality, capture efficiency, and resolution of major kidney compartments and cell types. Sequencing is performed on Illumina platforms with platform-appropriate depth, followed by preprocessing using platform-specific pipelines and downstream analysis in R/Python workflows (e.g., Seurat or equivalent) with normalization and batch correction as needed. Planned analyses include identification of cell-type and sub-cell-type signatures in spatial context, mapping of injury patterns (e.g., fibrosis/inflammation/vascular remodeling), and comparative molecular profiling across disease categories and therapy exposure groups with adjustment for relevant covariates.
Digital pathology and centralized histopathology review:
Digitized clinical stains and available diagnostic images are used for centralized review and standardized lesion scoring by renal pathologists. When applicable, diabetic kidney disease (DKD) is classified using established renal pathology criteria. Specimen adequacy metrics are used to guide analytic inclusion and sensitivity analyses.
Linked clinical data (high level):
Clinical data are harmonized across sites to support clinicopathologic and molecular integration, including medication exposure history and relevant laboratory and diagnostic variables. Longitudinal clinical information is used to contextualize molecular and histologic findings for downstream modeling.
Statistical and integrative analytic approach:
Analytic methods include differential expression and pathway analyses with appropriate multiple-testing control and covariate adjustment. Integrative modeling may combine molecular, histologic, and clinical domains using dimension reduction and regularized approaches to derive molecular signatures associated with disease state and therapy exposure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biopsy-confirmed Diabetic Kidney Disease Cohort | – | Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Drug: Renin-angiotensin-aldosterone system blockade, Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Drug: Mineralocorticoid Receptor Antagonists(MRAs)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 | – | Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Drug: Renin-angiotensin-aldosterone system blockade, Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Drug: Mineralocorticoid Receptor Antagonists(MRAs)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 | – | Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Drug: Renin-angiotensin-aldosterone system blockade, Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Drug: Mineralocorticoid Receptor Antagonists(MRAs)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 | – | Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Drug: Renin-angiotensin-aldosterone system blockade, Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Drug: Mineralocorticoid Receptor Antagonists(MRAs)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- TRIDENT 2.0 will enroll approximately 200 participants across multiple sites. Eligible participants include: * Patients with diabetic kidney disease (DKD) confirmed by clinically indicated biopsy. * Patients with other kidney diseases (disease controls). * Living kidney donors (donor biopsy tissue). * Patients undergoing nephrectomy (non-tumor, adjacent normal tissue when available). All participants must provide informed consent for release of one H\&E slide from their clinical biopsy or surgical specimen and for abstraction of relevant clinical data.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium-glucose cotransporter 2 inhibitors (SGLT2i)Also: SGLT2 inhibitorsStandard-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. | Drug | Biopsy-confirmed Diabetic Kidney Disease Cohort, Disease Control Kidney Disease Cohort, Living Kidney Donor Cohort, Nephrectomy Control Cohort |
| Renin-angiotensin-aldosterone system blockadeStandard-of-care exposure to renin-angiotensin-aldosterone system blockade documented from medication history for observational comparisons. | Drug | Biopsy-confirmed Diabetic Kidney Disease Cohort, Disease Control Kidney Disease Cohort, Living Kidney Donor Cohort, Nephrectomy Control Cohort |
| Glucagon-like peptide-1 receptor agonists (GLP 1 RA)Also: GLP-1 receptor agonistsStandard-of-care exposure documented from medication history for observational comparisons. | Drug | Biopsy-confirmed Diabetic Kidney Disease Cohort, Disease Control Kidney Disease Cohort, Living Kidney Donor Cohort, Nephrectomy Control Cohort |
| Mineralocorticoid Receptor Antagonists(MRAs)Also: MRAsStandard-of-care exposure documented from medication history for observational comparisons. | Drug | Biopsy-confirmed Diabetic Kidney Disease Cohort, Disease Control Kidney Disease Cohort, Living Kidney Donor Cohort, Nephrectomy Control Cohort |
Primary outcome
Change in Kidney Tissue molecular fingerprint
Time frame: Baseline enrollment to 18 months.
Change/differences in kidney tissue molecular "fingerprint" (molecular pathways / spatial gene expression signatures derived from archived kidney tissue) comparing participants exposed to sodium-glucose cotransporter 2 inhibitors versus controls and participants on other therapies. Tissue profiling includes single-cell spatial transcriptomics with differential expression and pathway analyses stratified by therapy exposure.
6 secondary outcomes
Change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline to 18 months
Change in urine protein/creatinine ratio
Time frame: Baseline to 6 months.
Descriptive histopathology features and spatial gene expression patterns across cohorts
Time frame: At enrollment/baseline (Single assessment on the archived clinical specimen slide)
Associations between histopathological features and clinical outcomes
Time frame: Up to 3 years (longitudinal outcome abstraction, including dialysis/transplant/kidney failure/mortality as captured).
Associations between histopathological features and prior medication exposures
Time frame: Baseline (prior/current medication exposure history at enrollment).
Feasibility metrics
Time frame: During study accrual and specimen acquisition (up to 3 years).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katalin Susztak, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies and Kidney Diseases, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaia Coppock, MD (2673030158, Gaia.Coppock@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Kidney Tissue molecular fingerprint (time frame: Baseline enrollment to 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.