Transformative Research In DiabEtic NephropaThy
University of Pennsylvania
Summary
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.
Description
Progress in the area of diabetic kidney research leading to new therapeutics development has been very limited. Indeed, no new medicines indicated for the treatment of chronic kidney disease (CKD) have been approved since ARB's have become standard of care nearly 15 years ago. Several factors explain the limited progress including but not limited to; a) animal and cell culture models do not recapitulate human DKD b) human genetic studies so far have failed to identify reproducible genetic variants associated with DKD c) the clinical manifestation of DKD is heterogeneous and might have even cha…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- 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 ma…
Interventions
- OtherThere is no intervention
There are no interventions
Locations (17)
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- University of Southern CaliforniaLos Angeles, California
- Stanford UniversityPalo Alto, California
- Yale UniversityNew Haven, Connecticut
- Northwestern UniversityChicago, Illinois
- University of MichiganAnn Arbor, Michigan