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Transformative Research In Diabetic Nephropathy

Overview

About this study

The purpose of this study 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 09/30/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Silvia de Oliveira Titan, M.D., Ph.D.

Contact us for the latest status

Contact information:

Carly Banks CCRP

(507) 255-4347

Banks.Carly@mayo.edu

More information

Publications

Publications are currently not available

More about research at Mayo Clinic

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CLS-20590070

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