NCT02986984

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Dec 2016Jun 2027

Study Start

First participant enrolled

December 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

10.5 years

First QC Date

December 6, 2016

Last Update Submit

February 25, 2026

Conditions

Diabetic NephropathiesDiabetic Glomerulosclerosis

Keywords

DiabetesChronic kidney diseaseProgressionGenomicsTranscriptomics

Outcome Measures

Primary Outcomes (1)

  • Rapid progression of kidney function loss

    • Identification of epigenetic, genetic, renal, genomic, and biomarker profiles that differentiates patients with rapid GFR decline (\>5cc/min) from those with slower (\<5cc/min) rate of progression.

    up to three years

Secondary Outcomes (1)

  • Serious Adverse Events

    up to three years

Study Arms (2)

Confirmed Diabetic Nephropathy

Patients undergoing a clinically indicated kidney biopsy with a history of diabetes who satisfy pre-specified criteria for diabetic nephropathy.

Other: There is no intervention

Confirmed Non-diabetic Nephropathy

Patients undergoing a clinically indicated kidney biopsy with a history of diabetes who fail pre-specified criteria for diabetic nephropathy.

Other: There is no intervention

Interventions

There is no interventionOTHER

There are no interventions

Also known as: There are no interventions
Confirmed Diabetic NephropathyConfirmed Non-diabetic Nephropathy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults (18 years of age and older) with diabetes who are scheduled to have a clinically-indicated kidney biopsy.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

ACTIVE NOT RECRUITING

Stanford University

Palo Alto, California, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

ACTIVE NOT RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

ACTIVE NOT RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (4)

  • Townsend RR, Guarnieri P, Argyropoulos C, Blady S, Boustany-Kari CM, Devalaraja-Narashimha K, Morton L, Mottl AK, Patel U, Palmer M, Ross MJ, Sarov-Blat L, Steinbugler K, Susztak K; TRIDENT Study Investigators. Rationale and design of the Transformative Research in Diabetic Nephropathy (TRIDENT) Study. Kidney Int. 2020 Jan;97(1):10-13. doi: 10.1016/j.kint.2019.09.020. No abstract available.

    PMID: 31901339BACKGROUND

  • Abedini A, Zhu YO, Chatterjee S, Halasz G, Devalaraja-Narashimha K, Shrestha R, S Balzer M, Park J, Zhou T, Ma Z, Sullivan KM, Hu H, Sheng X, Liu H, Wei Y, Boustany-Kari CM, Patel U, Almaani S, Palmer M, Townsend R, Blady S, Hogan J, Morton L, Susztak K; TRIDENT Study Investigators. Urinary Single-Cell Profiling Captures the Cellular Diversity of the Kidney. J Am Soc Nephrol. 2021 Mar;32(3):614-627. doi: 10.1681/ASN.2020050757. Epub 2021 Feb 2.

    PMID: 33531352RESULT

  • Palmer MB, Abedini A, Jackson C, Blady S, Chatterjee S, Sullivan KM, Townsend RR, Brodbeck J, Almaani S, Srivastava A, Avasare R, Ross MJ, Mottl AK, Argyropoulos C, Hogan J, Susztak K. The Role of Glomerular Epithelial Injury in Kidney Function Decline in Patients With Diabetic Kidney Disease in the TRIDENT Cohort. Kidney Int Rep. 2021 Feb 3;6(4):1066-1080. doi: 10.1016/j.ekir.2021.01.025. eCollection 2021 Apr.

    PMID: 33912757RESULT

  • Hogan JJ, Owen JG, Blady SJ, Almaani S, Avasare RS, Bansal S, Lenz O, Luciano RL, Parikh SV, Ross MJ, Sharma D, Szerlip H, Wadhwani S, Townsend RR, Palmer MB, Susztak K, Mottl AK; TRIDENT Study Investigators. The Feasibility and Safety of Obtaining Research Kidney Biopsy Cores in Patients with Diabetes: An Interim Analysis of the TRIDENT Study. Clin J Am Soc Nephrol. 2020 Jul 1;15(7):1024-1026. doi: 10.2215/CJN.13061019. Epub 2020 Apr 27. No abstract available.

    PMID: 32341009RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Buffy Coat (Germline DNA) Kidney Biopsy Cores Urine and blood aliquots for RNA

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes MellitusRenal Insufficiency, ChronicDisease Progression

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katalin Susztak, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katalin Susztak, MD, PhD

CONTACT

646-541-4079ksusztak@pennmedicine.upenn.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 8, 2016

Study Start

December 1, 2016

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(17)