Research on kidney disease in diabetes patients
Transformative Research In DiabEtic NephropaThy
University of Pennsylvania · NCT02986984
This study is testing how kidney biopsies can help find out why some people with diabetes have faster kidney problems than others, to look for new treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 17 sites (Little Rock, Arkansas and 16 other locations) |
| Trial ID | NCT02986984 on ClinicalTrials.gov |
What this trial studies
This observational cohort study focuses on patients with diabetes who are undergoing kidney biopsies to collect and analyze kidney tissue, blood, urine, and genetic materials. The goal is to identify molecular pathways and biomarkers that differentiate patients with rapid kidney function decline from those with slower progression. By utilizing high-throughput genomic analysis, the study aims to uncover potential therapeutic targets for diabetic kidney disease (DKD). Each clinical site will enroll participants and manage the biopsy sample collection as per the TRIDENT protocol.
Who should consider this trial
Good fit: Ideal candidates include adults with Type 1 or Type 2 diabetes who are scheduled for a medically indicated kidney biopsy.
Not a fit: Patients with end-stage renal disease or those who have received dialysis for more than 30 days prior to the biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new therapeutic targets for treating diabetic kidney disease.
How similar studies have performed: While progress in diabetic kidney disease research has been limited, this study's approach is novel and aims to address gaps in understanding DKD.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Little Rock, Arkansas and 16 other locations
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (RECRUITING)
- University of Southern California — Los Angeles, California, United States (ACTIVE_NOT_RECRUITING)
- Stanford University — Palo Alto, California, United States (RECRUITING)
- Yale University — New Haven, Connecticut, United States (RECRUITING)
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (ACTIVE_NOT_RECRUITING)
- University of New Mexico — Albuquerque, New Mexico, United States (RECRUITING)
- Mount Sinai Hospital — New York, New York, United States (RECRUITING)
- Columbia University — New York, New York, United States (ACTIVE_NOT_RECRUITING)
- Albert Einstein College of Medicine — The Bronx, New York, United States (ACTIVE_NOT_RECRUITING)
- University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
- Ohio State University — Columbus, Ohio, United States (RECRUITING)
- Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (RECRUITING)
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Katalin Susztak, MD — University of Pennsylvania
- Study coordinator: Katalin Susztak, MD, PhD
- Email: ksusztak@pennmedicine.upenn.edu
- Phone: 646-541-4079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Nephropathies, Diabetic Glomerulosclerosis, Diabetes, Chronic kidney disease, Progression, Genomics, Transcriptomics