Research on kidney disease in diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study focuses on patients with diabetes who are undergoing kidney biopsies to collect and analyze kidney tissue, blood, urine, and genetic materials. The goal is to identify molecular pathways and biomarkers that differentiate patients with rapid kidney function decline from those with slower progression. By utilizing high-throughput genomic analysis, the study aims to uncover potential therapeutic targets for diabetic kidney disease (DKD). Each clinical site will enroll participants and manage the biopsy sample collection as per the TRIDENT protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Type 1 and 2 Diabetes by American Diabetes Association (ADA) criteria
* Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
* Able to provide informed consent
* Adult participants
* Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist

Exclusion Criteria:

* End Stage Renal Disease (ESRD), defined as chronic dialysis or kidney transplant
* History of receiving dialysis for more than 30 days prior to biopsy
* Institutionalized
* Solid organ or bone marrow transplant recipient at time of first kidney biopsy
* Less than 3-year life expectancy
* History of active alcohol and/or substance abuse that in the investigator's assessment would impair the subject's ability to comply with the protocol
* Unable to provide informed consent
* Evidence of active cancer requiring treatment, other than non-melanoma skin cancer

Where it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• University of New Mexico
  Albuquerque, New Mexico, United States Recruiting
• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Katalin Susztak, MD — University of Pennsylvania
• Study coordinator: Katalin Susztak, MD, PhD
• Email: ksusztak@pennmedicine.upenn.edu
• Phone: 646-541-4079

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transformative 2.0 for diabetic kidney disease

  This project will try to see if adults with diabetic kidney disease who take SGLT2 diabetes medicines have different biological patterns in archived kidney tissue than similar people who do not take these medicines.

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• Formoterol for diabetic kidney disease

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  Recruiting Phase 2 Medical University of South Carolina · Charleston, South Carolina · NCT07022418

• Epithelial Dysmetabolism and Kidney Fibrosis in ANCA Vasculitis

  This study tests whether alterations in tubulo-interstitial metabolism relate to how quickly kidney function deteriorates in people with ANCA-associated vasculitis compared to other nephropathies.

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• Effects of low oxygen levels on kidney function in healthy individuals and diabetes patients

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• Evaluating WAL0921 for kidney diseases

  This study is testing a new drug called WAL0921 to see if it can help people with different types of kidney diseases feel better.

  Recruiting at 25 sites Phase 2 Walden Biosciences · Los Angeles, California and 49 other locations · NCT06466135

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.