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Observational Study for Diabetic Kidney Disease

This is an observational study for people with diabetes who are having a kidney biopsy for medical reasons. The study aims to understand why some people with diabetic kidney disease (DKD) experience a rapid decline in kidney function, while others do not. Researchers will collect and study kidney tissue, blood, urine, and genetic material to identify specific markers (biomarkers) and biological processes that are linked to how quickly kidney function changes. The goal is to find new targets for treatments for DKD. You can participate if you are an adult with type 1 or type 2 diabetes, are willing to follow study requirements, can give informed consent, and are scheduled for a medically necessary kidney biopsy.

Study design
This is an observational study, meaning there are no interventions or treatments being tested. Researchers plan to enroll 400 participants.
What's involved
You would need to fully participate in follow-up appointments at a clinical study site. The study involves collecting kidney tissue, blood, urine, and genetic materials.
Compensation
Not stated in the trial record.
Follow-up
Researchers will observe changes in kidney function for up to three years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02986984

Transformative Research in Diabetic Nephropathy

Recruiting
Not specifiedAges 18+Observational
University of Pennsylvania
~400 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:There is no intervention

At a glance

Recruiting sites
13 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rapid progression of kidney function loss
Measured over up to three years

Conditions

Diabetic Nephropathies
Diabetic Glomerulosclerosis

Explore related trials

Chronic Kidney DiseaseDiabetes MellitusDiabetic Nephropathy

Where it's being run

17 sites across 13 states
New York3
California2
Pennsylvania2
Arkansas1
Connecticut1
Illinois1
Michigan1
New Mexico1

Study leadership

  • Katalin Susztak, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Katalin Susztak, MD, PhD
[email protected]
646-541-4079
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rapid progression of kidney function lossup to three years

    • 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.