RECRUITING
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Transformative Research in Diabetic Nephropathy
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.
Conditions:
🦠 Diabetic Nephropathies 🦠 Diabetic Glomerulosclerosis
🗓️ Study Start (Actual) December 2016
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 400
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Little Rock, Arkansas, United States
📍 Los Angeles, California, United States
📍 Palo Alto, California, United States
📍 New Haven, Connecticut, United States
📍 Chicago, Illinois, United States
📍 Ann Arbor, Michigan, United States
📍 Albuquerque, New Mexico, United States
📍 Bronx, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Chapel Hill, North Carolina, United States
📍 Columbus, Ohio, United States
📍 Portland, Oregon, United States
📍 Allentown, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 San Antonio, Texas, United States
📍 Charlottesville, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 December 2016
  • First Submitted that Met QC Criteria 7 December 2016
  • First Posted 8 December 2016

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 January 2024
  • Last Update Posted 9 January 2024
  • Last Verified January 2024
I'm interested ...!!