Clinical Trial: Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary: 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.
Sponsor: Istanbul University

Current Primary Outcome: 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 initiation of renal replacement therapies.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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).
  • Partial remission [ Time Frame: 5-10 years ]
    Absence of complete remission, proteinuria reduction of >50% (and a proteinuria value of <3.5 g/24h in patients with nephrotic range proteinuria at baseline), and stabilization (±25%) or improvement in renal function.


Original Secondary Outcome:

Information By: Istanbul University

Dates:
Date Received: April 16, 2017
Date Started: March 1, 2017
Date Completion: September 2017
Last Updated: May 17, 2017
Last Verified: May 2017