Transformative Research in Diabetic Nephropathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Pennsylvania

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • There is no intervention

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Pennsylvania

Lead sponsor

MOUNT SINAI HOSPITAL

Collaborator

University of North Carolina

Collaborator

Northwestern University

Collaborator

University of New Mexico

Collaborator

Stanford University

Collaborator

The University of Texas Health Science Center at San Antonio

Collaborator

Ohio State University

Collaborator

Yale University

Collaborator

Albert Einstein College of Medicine

Collaborator

Oregon Health and Science University

Collaborator

Lehigh Valley Health Network

Collaborator

University of Arkansas

Collaborator

University of Southern California

Collaborator

University of Virginia

Collaborator

Regeneron Pharmaceuticals

Collaborator

Boehringer Ingelheim

Collaborator

GlaxoSmithKline

Collaborator

Gilead Sciences

Collaborator

Juvenile Diabetes Research Foundation

Collaborator

Novo Nordisk A/S

Collaborator