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Transformative Research in Diabetic Nephropathy

Recruitingn/aAges 18 Years - 100 YearsAllUniversity of Pennsylvania
NCT02986984 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (\> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.

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📋 Eligibility rules (as published)
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
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What it tests

  • There is no intervention
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Where

17 sites
University of Arkansas for Medical Sciences
Little Rock, United States
University of Southern California
Los Angeles, United States
Stanford University
Palo Alto, United States
Yale University
New Haven, United States
Northwestern University
Chicago, United States
University of Michigan
Ann Arbor, United States
University of New Mexico
Albuquerque, United States
Mount Sinai Hospital
New York, United States

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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