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Transformative Research in Diabetic Nephropathy (TRIDENT)

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ClinicalTrials.gov Identifier: NCT02986984
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : September 18, 2017
Sponsor:
Collaborators:
Columbia University
Mount Sinai Hospital, New York
University of Michigan
University of California, San Diego
University of North Carolina
University of Texas
Case Western Reserve University
Vanderbilt University
University of Toronto
Stanford University
GlaxoSmithKline
Boehringer Ingelheim
Regeneron Pharmaceuticals
University of Florida
Northwestern University
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment
Diabetic Nephropathies Diabetic Glomerulosclerosis Other: There is no intervention

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transformative Research In DiabEtic NephropaThy
Study Start Date : December 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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
There are no interventions
Other Name: There are no interventions
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
There are no interventions
Other Name: There are no interventions



Primary Outcome Measures :
  1. Rapid progression of kidney function loss [ Time Frame: up to three years ]
    • 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.


Secondary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: up to three years ]
    Prolonged hospitalization or need for intervention after kidney biopsy


Biospecimen Retention:   Samples With DNA
Buffy Coat (Germline DNA) Kidney Biopsy Cores Urine and blood aliquots for RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults (18 years of age and older) with diabetes who are scheduled to have a clinically-indicated kidney biopsy.
Criteria

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
  • Institutionalized
  • Solid organ or bone marrow transplant recipient at time of first kidney biopsy
  • Less than 3-year life expectancy
  • Known alcohol or substance abuse
  • Unable to provide informed consent
  • Evidence of active cancer other than non-melanoma skin cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986984


Contacts
Contact: Raymond R Townsend, MD 215-614-0423 townsend@upenn.edu
Contact: Shira Blady, BS 215-349-8035 Shira.Blady@uphs.upenn.edu

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States
Contact: Richard Lafayette, MD       czar@stanford.edu   
University of California Active, not recruiting
San Diego, California, United States
United States, Florida
University of Florida Active, not recruiting
Miami, Florida, United States
United States, Illinois
Nothwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Tamara Isakova, MD, MMsc         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States
Contact: Matthias Kretzler, MD       kretzler@med.umich.edu   
United States, New York
Columbia University Active, not recruiting
New York, New York, United States
Mount Sinai Hospital Active, not recruiting
New York, New York, United States
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States
Contact: Amy K Mottl, MD       amy_mott@med.unc.edu   
United States, Ohio
Case Western Reserve University Active, not recruiting
Cleveland, Ohio, United States
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jonathan Hogan, MD    215-662-7934    Jonathan.Hogan2@uphs.upenn.edu   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States
Contact: Raymond Harris, MD       raymond.harris@Vanderbilt.Edu   
United States, Texas
University of Texas Southwestern Active, not recruiting
Dallas, Texas, United States
Canada, Ontario
University of Toronto Active, not recruiting
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Pennsylvania
Columbia University
Mount Sinai Hospital, New York
University of Michigan
University of California, San Diego
University of North Carolina
University of Texas
Case Western Reserve University
Vanderbilt University
University of Toronto
Stanford University
GlaxoSmithKline
Boehringer Ingelheim
Regeneron Pharmaceuticals
University of Florida
Northwestern University
Investigators
Principal Investigator: Katalin Susztak, MD University of Pennsylvania

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02986984     History of Changes
Other Study ID Numbers: 824503
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
Diabetes
Chronic kidney disease
Progression
Genomics
Transcriptomics

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases