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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-08

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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RESOLVE is a multicenter, observational cohort study to examine the post-transplant course of patients with FSGS and MCD across the lifespan. The study is designed to collect both retrospective and prospective data as well as biospecimens and patient reported information. With multiple enrollment options, the study will allow investigators to define the incidence and prevalence of FSGS recurrence, describe the post-transplant course of patients with FSGS and MCD across the lifespan, and develop a biorepository to support future translational research studies to explore relevant disease mechanisms.

Conditions

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Focal Segmental Glomerulosclerosis Minimal Change Disease FSGS MCD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Enrolled participants prior to transplant

Participants will be consented.

Biospecimen collection

Intervention Type OTHER

Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.

Data collection

Intervention Type OTHER

Data collection for all groups

Enrolled participant after transplant

Participants will be consented.

Biospecimen collection

Intervention Type OTHER

Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.

Data collection

Intervention Type OTHER

Data collection for all groups

Retrospective participant data

Waiver of consent for secondary use of existing data.

Data collection

Intervention Type OTHER

Data collection for all groups

Interventions

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Biospecimen collection

Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.

Intervention Type OTHER

Data collection

Data collection for all groups

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Retrospective non-consented participant group had a transplant from the year 2000 and onward.
* Diagnosis of FSGS or MCD in the native kidney (prior to transplant).

Exclusion Criteria

* Pathologic diagnosis other than FSGS or MCD
* FSGS or MCD secondary to a known disorder (e.g. lupus nephritis, Immunoglobulin A (IgA) nephropathy, malignancy)

Eligible Sex

ALL

Accepts Healthy Volunteers

No