RecruitingNCT02986984

Transformative Research in Diabetic Nephropathy

Transformative Research In DiabEtic NephropaThy

Sponsor

University of Pennsylvania

Enrollment

400 participants

Start Date

Dec 1, 2016

Study Type

OBSERVATIONAL

Conditions

Diabetic Nephropathies Diabetic Glomerulosclerosis

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting kidney tissue samples (through a procedure called a biopsy) from people with diabetes to better understand how diabetes causes kidney disease and to find markers in the blood and urine that can detect it early. **You may be eligible if...** - You have been diagnosed with Type 1 or Type 2 diabetes (by standard medical criteria) - You are an adult - Your doctor (a kidney specialist) has already recommended a kidney biopsy for medical reasons - You are willing to participate in follow-up visits and comply with study requirements - You are able to give informed consent **You may NOT be eligible if...** - You are already on dialysis or have had a kidney transplant (end-stage kidney disease) - You have a history of certain kidney diseases not related to diabetes - You have a bleeding disorder or are on medications that prevent safe biopsy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERThere is no intervention

There are no interventions

Locations(17)

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

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