Purpose

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.

Category

IRB Number
20170372HU
NCT Number
NCT02986984
Sponsor
University of Pennsylvania -



Study Contact

Principal Investigator
Shweta Bansal

Subrata Debnath
210-567-4700
nath@uthscsa.edu



Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    • 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
    • Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist

Exclusion Criteria

    • 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
    • Less than 3-year life expectancy
    • History of active alcohol and/or substance abuse that in the investigator's assessment would impair the subject's ability to comply with the protocol
    • Unable to provide informed consent
    • Evidence of active cancer requiring treatment, other than non-melanoma skin cancer

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective
Condition
  • Diabetic Nephropathies
  • Diabetic Glomerulosclerosis

    • Arm Groups

    ArmDescriptionIntervention

    Confirmed Diabetic Nephropathy

    		Patients undergoing a clinically indicated kidney biopsy with a history of diabetes who satisfy pre-specified criteria for diabetic nephropathy.
  • Other: There is no intervention

    There are no interventions

    Other names:

    • There are no interventions

    • Confirmed Non-diabetic Nephropathy

    		Patients undergoing a clinically indicated kidney biopsy with a history of diabetes who fail pre-specified criteria for diabetic nephropathy.
  • Other: There is no intervention

    There are no interventions

    Other names:

    • There are no interventions

    •