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Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis

Predictors of Disease Progression in Patients With Primary Focal Segmental Glomerulosclerosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03126201
Enrollment
86
Registered
2017-04-24
Start date
2016-12-31
Completion date
2017-11-30
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Segmental Glomerulosclerosis, Glomerulonephritis

Keywords

focal segmental glomerulosclerosis, disease progression

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.

Interventions

None listed

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Reduction in kidney function and/or progression to end stage renal disease5-10 yearsAt 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

MeasureTime frameDescription
Complete remission5-10 yearsProteinuria 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 remission5-10 yearsAbsence 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026