Recruiting

Observational StudyTransformative Research in Diabetic Nephropathy

Sponsor:

University of Pennsylvania

Code:

NCT02986984

Conditions

Diabetic Nephropathies

Diabetic Glomerulosclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

There is no intervention

Study Details

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.

Conditions

Diabetic Nephropathies

Diabetic Glomerulosclerosis

Study ID

NCT02986984

Start date

Dec, 2016

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Confirmed Diabetic Nephropathy

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

Confirmed Non-diabetic Nephropathy

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

Interventions

There is no intervention

There are no interventions

Primary outcome measure

Rapid progression of kidney function loss [ Time Frame: up to three years ]

Central Contacts and Locations

Central contacts

Katalin Susztak, MD, PhD

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

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Tawana Gibbs

501-686-5301 TGibbs2@uams.edu

Principal Investigator:

Manisha Singh, MD

Stanford University

Recruiting

Palo Alto, California, United States

Contacts

Kshama Mehta, PhD

650-736-1822 krmehta@stanford.edu

Principal Investigator:

Richard Lafayette, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Katrina Blount

203-737-1575 katrina.blount@yale.edu

Principal Investigator:

Randy Luciano, MD, PhD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Carlos Martinez

312-503-1808 carlos.martinez@northwestern.edu

Principal Investigator:

Tamara Isakova, MD, MMsc

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Hugo Vilchis

505-272-5503 HVilchis@salud.unm.edu

Principal Investigator:

Christos Argyropoulos, MD, MSc, PhD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Stephanie Pagan

212-241-0059 stephanie.pagan@mssm.edu

Principal Investigator:

Kirk Campbell, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Sara Kelley

919-445-2658 Sara_kelley@med.unc.edu

Principal Investigator:

Amy K Mottl, MD, MPH

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Melissa Riley

614-293-9904 Melissa.Riley@osumc.edu

Principal Investigator:

Salem Almaani, MD, MS

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Tatevik Mazmanyan

503-494-9548 mazmanya@ohsu.edu

Principal Investigator:

Rupali Avasare, MD

Lehigh Valley Health Network

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Mary Sobotor

610-402-1592 Mary.Sobotor@lvhn.org

Principal Investigator:

Nelson Kopyt, DO

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mustafa AL-Obaidi, MD

215-349-8035 mustafa.alobaidi@pennmedicine.upenn.edu

Principal Investigator:

Gaia Coppock, MD

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Chakradhar Velagapudi

210-617-5300 velagapudi@uthscsa.edu

Principal Investigator:

Shweta Bansal, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Igor Shumilin

434-924-9691 IAS2N@hscmail.mcc.virginia.edu

Principal Investigator:

Julia Scialla, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

Diabetes
Chronic kidney disease
Progression
Genomics
Transcriptomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.