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Lay Description

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

  • Diabetes
  • Wounds and Injuries
IRB Number
20180225HU
NCT Number
ct.gov registration not required
Open to Enrollment
Yes

Eligibility

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

Inclusion Criteria

Exclusion Criteria

Study Design

Arm Groups

Study Contact

Regulatory Point of Contact
Inez Cruz
(210) 358-9904
cruzi@uthscsa.edu

Regulatory Point of Contact
Jennifer Daniels
(210) 562-5653
danielsj4@uthscsa.edu

Regulatory Point of Contact
Bailey Preikschat
(210) 562-5653
preikschat@uthscsa.edu

Local Recruitment Point of Contact
Jennifer Daniels
(210) 562-5653
danielsj4@uthscsa.edu

Local Recruitment Point of Contact
Bailey Preikschat
(210) 562-5653
preikschat@uthscsa.edu

Principal Investigator
Inez Cruz