Transformative Research in Diabetic Nephropathy

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.

Conditions

Diabetic Nephropathies, Diabetic Glomerulosclerosis

Study Overview

Study Details

Study overview

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.

Transformative Research In DiabEtic NephropaThy

Transformative Research in Diabetic Nephropathy

Condition
Diabetic Nephropathies
Intervention / Treatment

-

Contacts and Locations

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Palo Alto

Stanford University, Palo Alto, California, United States,

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Albuquerque

University of New Mexico, Albuquerque, New Mexico, United States, 87131

Bronx

Albert Einstein College of Medicine, Bronx, New York, United States, 10461

New York

Mount Sinai Hospital, New York, New York, United States, 10029

New York

Columbia University, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Katalin Susztak, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2025-06