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TRIDENT 2

Recruiting

Transformative Research in Diabetic Nephropathy 2.0

Transformative Research in Diabetic Nephropathy 2.0: A Proof of Principle Study of SGLT2 Inhibitors (TRIDENT 2.0)

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

1

Estimated enrollment

200

Study population

Chronic kidney disease, Type 2 diabetes

Eligibility highlights

•eGFR ≥10

Primary endpoint

•Kidney Tissue molecular fingerprint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07444203
Org study ID849580

Timeline

Milestones

Study start2025-11-12actual
Study first posted2026-03-02actual
Last update posted2026-03-02actual
Primary completion2027-05-30estimated
Study completion2028-11-12estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted
Sampling methodNon probability sample

Study population text

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.

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney
3
Other (unclassified)
3
Other clinical outcomes
1

Renal / kidney

3 endpoints
Primary/protocol endpoint

Change in Kidney Tissue molecular fingerprint

Time frame:Baseline enrollment to 18 months.

change from baseline, improvement

Secondary/protocol endpoint

Change in estimated glomerular filtration rate (eGFR)

Time frame:Baseline to 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change in urine protein/creatinine ratio

Time frame:Baseline to 6 months.

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Feasibility metrics

Time frame:During study accrual and specimen acquisition (up to 3 years).

descriptive

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Descriptive histopathology features and spatial gene expression patterns across cohorts

Time frame:At enrollment/baseline (Single assessment on the archived clinical specimen slide)

descriptive

Secondary/protocol endpoint/low confidence

Associations between histopathological features and clinical outcomes

Time frame:Up to 3 years (longitudinal outcome abstraction, including dialysis/transplant/kidney failure/mortality as captured).

descriptive

Secondary/protocol endpoint/low confidence

Associations between histopathological features and prior medication exposures

Time frame:Baseline (prior/current medication exposure history at enrollment).

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.