Transformative Research in Diabetic Nephropathy

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.

Conditions

• Diabetic Nephropathies
• Diabetic Glomerulosclerosis

Interventions

OTHER

There is no intervention

There are no interventions

Sponsors & Collaborators

• MOUNT SINAI HOSPITAL

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• Stanford University

  collaborator OTHER

• The University of Texas Health Science Center at San Antonio

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Yale University

  collaborator OTHER

• Albert Einstein College of Medicine

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Lehigh Valley Health Network

  collaborator OTHER

• University of Arkansas

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• Boehringer Ingelheim

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• Gilead Sciences

  collaborator INDUSTRY

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• Novo Nordisk A/S

  collaborator INDUSTRY

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Katalin Susztak, MD · University of Pennsylvania

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• United States

Study Locations