Transformative Research In DiabEtic NephropaThy

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
University of Southern California
ACTIVE_NOT_RECRUITING
Los Angeles
Stanford University
RECRUITING
Palo Alto
Connecticut
Yale University
RECRUITING
New Haven
Illinois
Northwestern University
RECRUITING
Chicago
Michigan
University of Michigan
ACTIVE_NOT_RECRUITING
Ann Arbor
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New Mexico
University of New Mexico
RECRUITING
Albuquerque
New York
Columbia University
ACTIVE_NOT_RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
Albert Einstein College of Medicine
ACTIVE_NOT_RECRUITING
The Bronx
Ohio
Ohio State University
RECRUITING
Columbus
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Lehigh Valley Health Network
RECRUITING
Allentown
University of Pennsylvania
RECRUITING
Philadelphia
Texas
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Raymond R Townsend, MD
townsend@upenn.edu
267-738-3431
Time Frame
Start Date: 2016-12
Estimated Completion Date: 2027-06
Participants
Target number of participants: 400
Treatments
Confirmed Diabetic Nephropathy
Patients undergoing a clinically indicated kidney biopsy with a history of diabetes who satisfy pre-specified criteria for diabetic nephropathy.
Confirmed Non-diabetic Nephropathy
Patients undergoing a clinically indicated kidney biopsy with a history of diabetes who fail pre-specified criteria for diabetic nephropathy.
Related Therapeutic Areas
Sponsors
Collaborators: University of New Mexico, Boehringer Ingelheim, Regeneron Pharmaceuticals, University of Southern California, The University of Texas Health Science Center at San Antonio, Lehigh Valley Health Network, Stanford University, University of Arkansas, Albert Einstein College of Medicine, Oregon Health and Science University, Gilead Sciences, MOUNT SINAI HOSPITAL, Juvenile Diabetes Research Foundation, University of North Carolina, Yale University, Northwestern University, University of Virginia, Novo Nordisk A/S, Ohio State University, GlaxoSmithKline
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov