Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05650619
Status
Recruiting
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Conditions

  • FSGS
  • Focal Segmental Glomerulosclerosis
  • MCD
  • Minimal Change Disease

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen collection — OTHER
    Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.
  • Data collection — OTHER
    Data collection for all groups

Study Details

The morbidity of recurrence of focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) after transplant is well-recognized and include contemporary reduction in quality of life, edema, early graft loss and mortality. Efforts to understand its mechanisms and improve its treatment have been limited by small sample sizes in single center studies and misclassification in registry studies. Recent advances in the understanding of the mechanisms of FSGS in the native kidney has reinvigorated the scientific community to develop a collaborative community to advance research into the epidemiology, mechanisms, interventions, and outcomes. The purpose of RESOLVE is to gather a group of people with FSGS and MCD that have had or will have a kidney transplant to create a bank of information and biospecimens so researchers can more effectively study these diseases.

Key Dates

Start date
Dec 8, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Enrolled participants prior to transplant
    Participants will be consented.
  • Arm: Enrolled participant after transplant
    Participants will be consented.
  • Arm: Retrospective participant data
    Waiver of consent for secondary use of existing data.

Primary Outcome Measure

Time to FSGS Recurrence [ Time Frame: 2 years after transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
[email protected]
734-232-4830
Eloise Salmon, MD (PRINCIPAL_INVESTIGATOR)
Debbie Gipson, MD (SUB_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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