Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis

Completed

• Conditions: Glomerulonephritis; Focal Segmental Glomerulosclerosis

• Registration Number: NCT03126201
• Lead Sponsor: Istanbul University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-04-16
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Primary Completion: 2017-09
• Study Completion: 2017-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in kidney function and/or progression to end stage renal disease	5-10 years	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).

Secondary Outcome Measures

Name	Time	Method
Complete remission	5-10 years	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).
Partial remission	5-10 years	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.

Trial Locations

Locations (1)

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine; 🇹🇷 Istanbul, Turkey