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El ensayo clínico NCT07444203 (TRIDENT 2) para Nefropatías diabéticas, Enfermedades Renales, Insuficiencia renal crónica, Diabetes mellitus, tipo 2 está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Universidad de PensilvaniaTransformative Research in Diabetic Nephropathy 2.0 (TRIDENT 2) 200 Observacional
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07444203 (TRIDENT 2) es un estudio observacional para Nefropatías diabéticas, Enfermedades Renales, Insuficiencia renal crónica, Diabetes mellitus, tipo 2. Su estado actual es: reclutando. El estudio se inició el 12 de noviembre de 2025, con el objetivo de reclutar a 200 participantes. Dirigido por la Universidad de Pensilvania, se espera que finalice el 12 de noviembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 2 de marzo de 2026.
Resumen
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...Mostrar más
Descripción detallada
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 sit...Mostrar más
Título oficial
Transformative Research in Diabetic Nephropathy 2.0: A Proof of Principle Study of SGLT2 Inhibitors (TRIDENT 2.0)
Condiciones médicas
Nefropatías diabéticasEnfermedades RenalesInsuficiencia renal crónicaDiabetes mellitus, tipo 2Otros ID del estudio
- TRIDENT 2
- 849580
Número del NCT
Inicio del estudio (real)
2025-11-12
Última actualización
2026-03-02
Fecha de finalización (estimada)
2028-11-12
Inscripción (prevista)
200
Tipo de estudio
Observacional
Estado general
Reclutando
Palabras clave
Diabetic nephropathy
Chronic kidney disease
Diabetic kidney disease
Sodium-glucose cotransporter 2 inhibitors
Spatial transcriptomics
Kidney-protective therapy
Chronic kidney disease
Diabetic kidney disease
Sodium-glucose cotransporter 2 inhibitors
Spatial transcriptomics
Kidney-protective therapy
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
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...Mostrar más | 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. |
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. | 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. |
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. | 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. |
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. | 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. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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. | Baseline enrollment to 18 months. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change in estimated glomerular filtration rate (eGFR) | Change in eGFR calculated using the 2021 race-free CKD-EPI equation. | Baseline to 18 months |
Change in urine protein/creatinine ratio | Change in urine protein/creatinine ratio over follow-up. | 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. | 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. | 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. | Baseline (prior/current medication exposure history at enrollment). |
Feasibility metrics | Accrual rate by cohort, proportion of slides successfully retrieved, and slide quality metrics. | During study accrual and specimen acquisition (up to 3 years). |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- 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.
- 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.
Universidad de Pensilvania503 estudios activos para explorarParte responsable del estudio
Katalin Susztak, Investigador principal, MD, PhD, University of Pennsylvania
Contactos centrales del estudio
Contacto: Gaia Coppock, MD, 2673030158, [email protected]
Contacto: Mohammed Al Dulaimee, BS, 5853589733, [email protected]
1 Centros del estudio en 1 países
Pennsylvania
Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, 19104, United States
Gaia Coppock, MD, Contacto, 2673030158, [email protected]
Mohammed Al Dulaimee, BS, Contacto, 5853589733, [email protected]
Reclutando