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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "People can join only if they are already having a kidney biopsy or kidney surgery as part of their regular medical care."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at kidney tissue to learn how SGLT2 inhibitors, a type of diabetes medicine, may affect kidney health over time. It is for adults with diabetic kidney disease and other groups who have a kidney biopsy or kidney surgery as part of regular care. No extra kidney biopsy is needed for research.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have an eGFR of at least 10, a measure of how well your kidneys filter blood.
  • Have had a kidney biopsy for medical care, a living kidney donor biopsy, or surgery to remove a kidney. For kidney surgery, tissue from outside the tumor must be available.
  • Be able and willing to give permission for researchers to use one kidney tissue slide and review your medical records.

Who can't join

  • You cannot give informed consent, meaning you cannot understand and agree to join.
  • Stored kidney tissue from your biopsy or surgery is not available to make a slide.
  • Your medical center's rules do not allow the needed tissue slide to be shared for research.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

PA