Transformative Research in Diabetic Nephropathy

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
University of Pennsylvania
Study ID
NCT02986984
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Glomerulosclerosis
  • Diabetic Nephropathies

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • There is no intervention — OTHER
    There are no interventions

Study Details

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.

Key Dates

Start date
Dec 31, 2016
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Confirmed Diabetic Nephropathy
    Patients undergoing a clinically indicated kidney biopsy with a history of diabetes who satisfy pre-specified criteria for diabetic nephropathy.
  • Arm: Confirmed Non-diabetic Nephropathy
    Patients undergoing a clinically indicated kidney biopsy with a history of diabetes who fail pre-specified criteria for diabetic nephropathy.

Primary Outcome Measure

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

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Tawana Gibbs
[email protected]
501-686-5301
Manisha Singh, MD (PRINCIPAL_INVESTIGATOR)
University of Southern CaliforniaLos AngelesCalifornia90033-
Stanford UniversityPalo AltoCalifornia-
Kshama Mehta, PhD
[email protected]
650-736-1822
Richard Lafayette, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06510
Katrina Blount
[email protected]
203-737-1575
Randy Luciano, MD, PhD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Carlos Martinez
[email protected]
312-503-1808
Tamara Isakova, MD, MMsc (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109-
University of New MexicoAlbuquerqueNew Mexico87131
Hugo Vilchis
[email protected]
505-272-5503
Christos Argyropoulos, MD, MSc, PhD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032-
Mount Sinai HospitalNew YorkNew York10029
Stephanie Pagan
[email protected]
212-241-0059
Kirk Campbell, MD (PRINCIPAL_INVESTIGATOR)
Albert Einstein College of MedicineThe BronxNew York10461-
University of North CarolinaChapel HillNorth Carolina27599
Sara Kelley
[email protected]
919-445-2658
Amy K Mottl, MD, MPH (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Melissa Riley
[email protected]
614-293-9904
Salem Almaani, MD, MS (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Tatevik Mazmanyan
[email protected]
503-494-9548
Rupali Avasare, MD (PRINCIPAL_INVESTIGATOR)
Lehigh Valley Health NetworkAllentownPennsylvania18103
Mary Sobotor
[email protected]
610-402-1592
Nelson Kopyt, DO (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Mustafa AL-Obaidi, MD
[email protected]
215-349-8035
Gaia Coppock, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Chakradhar Velagapudi
[email protected]
210-617-5300
Shweta Bansal, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22908
Igor Shumilin
[email protected]
434-924-9691
Julia Scialla, MD (PRINCIPAL_INVESTIGATOR)

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