RECRUITING

Transformative Research in Diabetic Nephropathy

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Conditions

Diabetic NephropathiesDiabetic GlomerulosclerosisDiabetesChronic kidney diseaseProgressionGenomicsTranscriptomics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transformative Research In DiabEtic NephropaThy

Quick Facts

Study Start:2016-12
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02986984

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Type 1 and 2 Diabetes by American Diabetes Association (ADA) criteria
  2. * Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
  3. * Able to provide informed consent
  4. * Adult participants
  5. * Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
  1. * End Stage Renal Disease (ESRD), defined as chronic dialysis or kidney transplant
  2. * History of receiving dialysis for more than 30 days prior to biopsy
  3. * Institutionalized
  4. * Solid organ or bone marrow transplant recipient at time of first kidney biopsy
  5. * Less than 3-year life expectancy
  6. * 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
  7. * Unable to provide informed consent
  8. * Evidence of active cancer requiring treatment, other than non-melanoma skin cancer

Contacts and Locations

Study Contact

Raymond R Townsend, MD
CONTACT
267-738-3431
townsend@upenn.edu

Principal Investigator

Katalin Susztak, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
University of Southern California
Los Angeles, California, 90033
United States
Stanford University
Palo Alto, California
United States
Yale University
New Haven, Connecticut, 06510
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Columbia University
New York, New York, 10032
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Ohio State University
Columbus, Ohio, 43210
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Katalin Susztak, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12
Study Completion Date2025-06

Study Record Updates

Study Start Date2016-12
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Diabetes
  • Chronic kidney disease
  • Progression
  • Genomics
  • Transcriptomics

Additional Relevant MeSH Terms

  • Diabetic Nephropathies
  • Diabetic Glomerulosclerosis