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OpenTrials
Completed

NCT Number: NCT03126201

Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis

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.

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Key information

Conditions

Glomerulonephritis Disease Attributes Disease Progression Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Focal Segmental Glomerulosclerosis Glomerulosclerosis, Focal Segmental Kidney Diseases Male Urogenital Diseases Nephritis Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Reduction in kidney function and/or progression to end stage renal disease

    Time frame: 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 outcomes

  1. Complete remission

    Time frame: 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).

  2. Partial remission

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Predictors of Disease Progression in Patients With Primary Focal Segmental Glomerulosclerosis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2017
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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