GlomerulonephritisNCT03126201
Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis
An observational study of Glomerulonephritis and Focal Segmental Glomerulosclerosis, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glomerulonephritis, Focal Segmental Glomerulosclerosis
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2016to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biopsy-proven primary focal segmental glomerulosclerosis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
Istanbul, 34093
About this study
Official title: 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.
Read the 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.
- Keywords
- focal segmental glomerulosclerosis, disease progression
- Medical subject headings
- Glomerulonephritis, Glomerulosclerosis, Focal Segmental, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients with biopsy-proven primary focal segmental glomerulosclerosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5-10 years
Secondary outcomes (2)
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).
Measured: 5-10 years
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.
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startDec 2016
- Primary completionSep 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlomerulonephritisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Caliskan, Istanbul University
- Investigators
- Yasar Caliskan, MD, Principal investigator, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126201
- Sponsor's protocol ID
- 333
- Status last verified
- Feb 2018
- First submitted
- 16 Apr 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22187987
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Disease Progression in Patients With Primary Focal Segmental Glomerulosclerosis
- ClinicalTrials.gov ID
- NCT03126201
- Acronym / sponsor ID
- 333
- Keywords
- focal segmental glomerulosclerosis, disease progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Patients with biopsy-proven primary focal segmental glomerulosclerosis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy-proven primary focal segmental glomerulosclerosis.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 development of kidney failure, which was defined as a category G5 CKD (eGFR <15 ml/min/1.73 m2).
2 secondary outcomes
Complete remission
Time frame: 5-10 years
Partial remission
Time frame: 5-10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Background: PubMed 22187987D'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasar Caliskan, MD principal investigator
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glomerulonephritis and Focal Segmental Glomerulosclerosis, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in kidney function and/or progression to end stage renal disease (time frame: 5-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03126201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.