NCT02986984 · University of Pennsylvania
Transformative Research in Diabetic Nephropathy
(TRIDENT)
What this study is about
This is a forward-looking, observational, group of participants study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Little Rock, Arkansas
- Los Angeles, California
- Palo Alto, California
- New Haven, Connecticut
- Chicago, Illinois
- Ann Arbor, Michigan
- Albuquerque, New Mexico
- New York, New York
- The Bronx, New York
- Chapel Hill, North Carolina
- Columbus, Ohio
- Portland, Oregon
And 4 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations