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

This trial does not accept healthy volunteers

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 population

Adults (18 years of age and older) with diabetes who are scheduled to have a clinically-indicated kidney biopsy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • There is no intervention

    Other intervention

    There are no interventions

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Confirmed Diabetic Nephropathy1 intervention
Group B: Confirmed Non-diabetic Nephropathy1 intervention

Trial outcomes

Primary outcomes

1

Rapid progression of kidney function loss

• Identification of epigenetic, genetic, renal, genomic, and biomarker profiles that differentiates patients with rapid GFR decline (\>5cc/min) from those with slower (\<5cc/min) rate of progression.

Time frame
up to three years

Secondary outcomes

1

Serious Adverse Events

Prolonged hospitalization or need for intervention after kidney biopsy

Time frame
up to three years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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