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

Study Overview
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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.

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.

Official Title
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Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD)

Conditions
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Focal Segmental Glomerulosclerosis, Minimal Change Disease, FSGS, MCD

Intervention / Treatment
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* Other: Biospecimen collection
* Other: Data collection


Participation Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrolled participants prior to transplant<br>Participants will be consented. | Other: Biospecimen collection<br>* Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.<br>Other: Data collection<br>* Data collection for all groups<br>|
| Enrolled participant after transplant<br>Participants will be consented. | Other: Biospecimen collection<br>* Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.<br>Other: Data collection<br>* Data collection for all groups<br>|
| Retrospective participant data<br>Waiver of consent for secondary use of existing data. | Other: Data collection<br>* Data collection for all groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to FSGS Recurrence |  | 2 years after transplant | 
| Time to Graft Failure |  | 2 years after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define the Endophenotypes in each group of recurrent FSGS and MCD | Classifications for the dataset using non-hierarchical clustering techniques | 2 years after transplant | 
| Proportion of recurrence and time to graft failure |  | 2 years after transplant | 
| Proportion with acute rejection |  | 2 years after transplant | 
| Proteinuria change over time |  | Baseline (at transplant), 2 years | 
| Proportion with delayed graft function |  | 2 years after transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney disease, Kidney transplant, Adult, Children, Recurrence