Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis

February 15, 2018 updated by: Yasar Caliskan, Istanbul University

Predictors of Disease Progression in Patients With 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with biopsy-proven primary focal segmental glomerulosclerosis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study Group
Patients with biopsy-proven primary focal segmental glomerulosclerosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5-10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5-10 years
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.
5-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

April 16, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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