Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis

Focal Segmental Glomerulosclerosis Clinical Trial

Official title:

Predictors of Disease Progression in Patients With Primary Focal Segmental Glomerulosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126201
• Other study ID #: 333
• Status: Completed
• Phase: N/A
• First received: April 16, 2017
• Last updated: February 15, 2018
• Start date: December 2016
• Est. completion date: November 2017

Study information

• Verified date: February 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease Progression
• Focal Segmental Glomerulosclerosis
• Glomerulonephritis
• Glomerulosclerosis, Focal Segmental

Locations

Country	Name	City	State
Turkey	Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

D'Agati VD, Kaskel FJ, Falk RJ. Focal segmental glomerulosclerosis. N Engl J Med. 2011 Dec 22;365(25):2398-411. doi: 10.1056/NEJMra1106556. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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