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NCT02986984Recruiting

Transformative Research in Diabetic Nephropathy

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
6 Dec 2016
Start date
Dec 2016
Primary completion date
Jun 2027
Lead sponsor
University of Pennsylvania
NCT number
NCT02986984

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From Dec 2016 to the primary completion date, Jun 2027
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of receiving dialysis for more than 30 days prior to biopsy
  • Solid organ or bone marrow transplant recipient at time of first kidney biopsy

Other illness

  • End Stage Renal Disease (ESRD), defined as chronic dialysis or kidney transplant
  • 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
  • Evidence of active cancer requiring treatment, other than non-melanoma skin cancer

Other

  • Institutionalized
  • Less than 3-year life expectancy
  • Unable to provide informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of New Mexico
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesRecruiting
Lehigh Valley Health Network
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AllentownUnited StatesRecruiting
University of Michigan
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Ann ArborUnited StatesActive, not recruiting
University of North Carolina
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Chapel HillUnited StatesRecruiting
University of Virginia
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CharlottesvilleUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
Ohio State University
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
University of Arkansas for Medical Sciences
Coordinator of this site? Confirm its status
Little RockUnited StatesRecruiting
University of Southern California
Coordinator of this site? Confirm its status
Los AngelesUnited StatesActive, not recruiting
Yale University
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New HavenUnited StatesRecruiting
Mount Sinai Hospital
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New YorkUnited StatesRecruiting
Columbia University
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New YorkUnited StatesActive, not recruiting
Stanford University
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Palo AltoUnited StatesRecruiting
University of Pennsylvania
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PhiladelphiaUnited StatesRecruiting
Oregon Health Science University
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PortlandUnited StatesRecruiting
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesRecruiting
Albert Einstein College of Medicine
Coordinator of this site? Confirm its status
The BronxUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.