Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis

NCT03126201 | Completed

• 1 other identifier: 333
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Glomerulonephritis; Focal Segmental Glomerulosclerosis

Keywords

focal segmental glomerulosclerosis; disease progression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complete remission

  5-10 years

• Partial remission

  5-10 years

Study Arms (1)

Study Group

Patients with biopsy-proven primary focal segmental glomerulosclerosis.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with biopsy-proven primary focal segmental glomerulosclerosis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

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

Istanbul, 34093, Turkey (Türkiye)

Location

Related 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. No abstract available.

  PMID: 22187987 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis; Glomerulosclerosis, Focal Segmental; Disease Progression

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasar Caliskan, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: April 24, 2017
• Study Start: December 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)