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
- Diseases
- Chronic kidney disease
- 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
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Lehigh Valley Health Network Coordinator of this site? Confirm its status | Allentown | United States | Recruiting |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Active, not recruiting |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Active, not recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Albert Einstein College of Medicine Coordinator of this site? Confirm its status | The Bronx | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.