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Transformative Research in Diabetic Nephropathy

RecruitingObservational study

Transformative Research In DiabEtic NephropaThy

Who can join

Ages 18 to 100 · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: University of Pennsylvania · Participants: 400 · Started: 2016-12

Contact the study team

Official record on ClinicalTrials.gov — NCT02986984

Locations in the U.S.

ArkansasUniversity of Arkansas for Medical Sciences, Little Rock
CaliforniaStanford University, Palo Alto
ConnecticutYale University, New Haven
IllinoisNorthwestern University, Chicago
New MexicoUniversity of New Mexico, Albuquerque
New YorkMount Sinai Hospital, New York
North CarolinaUniversity of North Carolina, Chapel Hill
OhioOhio State University, Columbus
OregonOregon Health & Science University, Portland
PennsylvaniaLehigh Valley Health Network, Allentown
University of Pennsylvania, Philadelphia
TexasUniversity of Texas Health Science Center at San Antonio, San Antonio
VirginiaUniversity of Virginia, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.