Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis

Study Overview
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Brief Summary
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Focal segmental glomerulosclerosis (FSGS) is one of the most common primary glomerular diseases leading to end stage renal disease. In this study, our aim is to evaluate the effects of histopathological, clinical, and laboratory features of patients with primary FSGS on the disease progression.

Detailed Description
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Focal segmental glomerulosclerosis (FSGS) is one of the most common primary glomerular diseases leading to end stage renal disease worldwide. Numerous studies have been conducted in order to identify the etiology of this debilitating disease. Beyond the etiological research, however, few studies managed to demonstrate the possible predictors of disease progression in patients. Therefore, we aim to evaluate the effects of histopathological, clinical, and laboratory features of patients with primary FSGS on the disease progression.

Official Title
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Predictors of Disease Progression in Patients With Primary Focal Segmental Glomerulosclerosis

Conditions
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Glomerulonephritis, Focal Segmental Glomerulosclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with biopsy-proven primary focal segmental glomerulosclerosis. Patients who have a renal biopsy available for reviewing including 8 or more glomeruli. Patients who have been followed-up for at least 6 months or have progressed to primary outcome regardless the duration of follow-up. Exclusion Criteria: Patients who have secondary focal segmental glomerulosclerosis attributable to any other condition (e.g., obesity, HIV, relevant drug exposure). Patients who have a genetic mutation or variation creating a tendency for developing focal segmental glomerulosclerosis. Patients who are unwilling or unable to consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

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 |
| --- | --- |
| Study Group<br>Patients with biopsy-proven primary focal segmental glomerulosclerosis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in kidney function and/or progression to end stage renal disease | At least a fifty-percent reduction in baseline estimated glomerular filtration rate (eGFR) or development of kidney failure, which was defined as a category G5 CKD (eGFR <15 ml/min/1.73 m2). | 5-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission | Proteinuria below 0.5 g/24h and an eGFR of ≥60 ml/min per 1.73 m2 (or a return of ±15% of baseline values in those with eGFR <60 ml/min per 1.73 m2). | 5-10 years | 
| Partial remission | Absence of complete remission, proteinuria reduction of >50% (and a proteinuria value of <3 g/24h in patients with nephrotic range proteinuria at baseline), and stabilization (±25%) or improvement in renal function. | 5-10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focal segmental glomerulosclerosis, disease progression