About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- There is no intervention
Treatment groups
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
MOUNT SINAI HOSPITAL
Collaborator
University of North Carolina
Collaborator
Northwestern University
Collaborator
University of New Mexico
Collaborator
Stanford University
Collaborator
The University of Texas Health Science Center at San Antonio
Collaborator
Ohio State University
Collaborator
Yale University
Collaborator
Albert Einstein College of Medicine
Collaborator
Oregon Health and Science University
Collaborator
Lehigh Valley Health Network
Collaborator
University of Arkansas
Collaborator
University of Southern California
Collaborator
University of Virginia
Collaborator
Regeneron Pharmaceuticals
Collaborator
Boehringer Ingelheim
Collaborator
GlaxoSmithKline
Collaborator
Gilead Sciences
Collaborator
Juvenile Diabetes Research Foundation
Collaborator
Novo Nordisk A/S
Collaborator