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Transformative Research in Diabetic Nephropathy

Sponsored by University of Pennsylvania

About this study

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.

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 changed since the original description d) DKD is a clinical diagnosis and it is not clear what percentage of patients have histological disease. Laboratory mice have served as invaluable tools to unders…

Where this study is enrolling (13)

Show all 13 locations
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.