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Trial record 10 of 60 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetic Nephropathies"

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 : May 14, 2018
Sponsor:
Collaborators:
Columbia University
Mount Sinai Hospital, New York
University of Michigan
University of North Carolina
Northwestern University
University of New Mexico
Stanford University
The University of Texas Health Science Center at San Antonio
Baylor Research Institute
Yale University
Ohio State University
Regeneron Pharmaceuticals
GlaxoSmithKline
Boehringer Ingelheim
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


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, Older Adult)
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 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

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: Kshama Mehta, PhD    650-736-1822    krmehta@stanford.edu   
Principal Investigator: Richard Lafayette, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Katrina Blount    203-737-1575    katrina.blount@yale.edu   
Contact: Erin Murphy       erin.l.murphy@yale.edu   
Principal Investigator: Randy Luciano, MD, PhD         
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Carlos Bidot    305-243-8793    CBidot2@med.miami.edu   
Principal Investigator: Oliver Lenz, MD, MBA         
United States, Illinois
Nothwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Carlos Martinez    312-503-1808    carlos.martinez@northwestern.edu   
Principal Investigator: Tamara Isakova, MD, MMsc         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Chrysta Lienczewski       boridley@med.umich.edu   
Contact: Amanda Williams    734-615-5017    amwi@med.umich.edu   
Principal Investigator: Matthias Kretzler, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Hugo Vilchis    505-272-5503    HVilchis@salud.unm.edu   
Principal Investigator: Christos Argyropoulos, MD, MSc, PhD         
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Garnette Mason    212-241-4824    Garnette.Mason@mssm.edu   
Principal Investigator: Kirk Campbell, MD         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Michael Toledo    212-305-6842    mt3013@cumc.columbia.edu   
Principal Investigator: Pietro A Canetta, MD, MSc         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Anne Froment    919-445-2622    anne_froment@med.unc.edu   
Principal Investigator: Amy K Mottl, MD, MPH         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States
Contact: Jennifer Rinehart    614-293-6205    Jennifer.Rinehart@osumc.edu   
Contact: Kara Frisch    614-685-6651    Kara.Frisch@osumc.edu   
Principal Investigator: Salem Almaani, MD, MS         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Shira Blady    215-349-8035    Shira.Blady@uphs.upenn.edu   
Principal Investigator: Jonathan Hogan, MD         
United States, Tennessee
Vanderbilt University Withdrawn
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Verlie Smilak    214-820-4628    VERLIE.SLIMAK@BSWHEALTH.ORG   
Principal Investigator: Harold Szerlip, MD, MS(Ed)         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Chakradhar Velagapudi    210-617-5300 ext 15323    velagapudi@uthscsa.edu   
Principal Investigator: Shweta Bansal, MD         
Sponsors and Collaborators
University of Pennsylvania
Columbia University
Mount Sinai Hospital, New York
University of Michigan
University of North Carolina
Northwestern University
University of New Mexico
Stanford University
The University of Texas Health Science Center at San Antonio
Baylor Research Institute
Yale University
Ohio State University
Regeneron Pharmaceuticals
GlaxoSmithKline
Boehringer Ingelheim
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: May 14, 2018
Last Verified: May 2018
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