Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT02986984

Transformative Research in Diabetic Nephropathy

Led by University of Pennsylvania · Updated on 2026-02-27

400

Participants Needed

17

Research Sites

547 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

M

MOUNT SINAI HOSPITAL

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Transformative Research in Diabetic Nephropathy

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association criteria
  • Willingness to comply with study requirements including full participation in follow-up visits
  • Ability to provide informed consent
  • Adult participants
  • Planned kidney biopsy prescribed by a nephrologist for medical reasons
Not Eligible

You will not qualify if you...

  • End-stage renal disease (chronic dialysis or kidney transplant)
  • History of dialysis for more than 30 days before biopsy
  • Institutionalized individuals
  • Solid organ or bone marrow transplant recipient at time of first kidney biopsy
  • Life expectancy less than 3 years
  • History of active alcohol or substance abuse impairing compliance
  • Unable to provide informed consent
  • Active cancer requiring treatment, except non-melanoma skin cancer

AI-Screening

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Trial Site Locations

Total: 17 locations

1

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

2

University of Southern California

Los Angeles, California, United States, 90033

Active, Not Recruiting

3

Stanford University

Palo Alto, California, United States

Actively Recruiting

4

Yale University

New Haven, Connecticut, United States, 06510

Actively Recruiting

5

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

6

University of Michigan

Ann Arbor, Michigan, United States, 48109

Active, Not Recruiting

7

University of New Mexico

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

8

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

9

Columbia University

New York, New York, United States, 10032

Active, Not Recruiting

10

Albert Einstein College of Medicine

The Bronx, New York, United States, 10461

Active, Not Recruiting

11

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

12

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

13

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

14

Lehigh Valley Health Network

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

15

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

16

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

17

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

K

Katalin Susztak, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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