Transformative Research in Diabetic Nephropathy
Recruiting · NCT02986984 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Pennsylvania
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 it is running
17 locations listed across 13 US states.
- University of Arkansas for Medical Sciences - Little Rock, Arkansas, United States
- University of Southern California - Los Angeles, California, United States
- Stanford University - Palo Alto, California, United States
- Yale University - New Haven, Connecticut, United States
- Northwestern University - Chicago, Illinois, United States
- University of Michigan - Ann Arbor, Michigan, United States
- University of New Mexico - Albuquerque, New Mexico, United States
- Mount Sinai Hospital - New York, New York, United States
- Columbia University - New York, New York, United States
- Albert Einstein College of Medicine - The Bronx, New York, United States
- University of North Carolina - Chapel Hill, North Carolina, United States
- Ohio State University - Columbus, Ohio, United States
- Oregon Health & Science University - Portland, Oregon, United States
- Lehigh Valley Health Network - Allentown, Pennsylvania, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- University of Texas Health Science Center at San Antonio - San Antonio, Texas, United States
- University of Virginia - Charlottesville, Virginia, United States