Predictive Determinants of Nephrotic Syndrome Remission in Patients With At-risk Polymorphism of … (NCT06443034) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Predictive Determinants of Nephrotic Syndrome Remission in Patients With At-risk Polymorphism of APOL1
France124 participantsStarted 2024-06-30
Plain-language summary
This is a multicentric retrospective observational cohort study.
As primary objective, the study aims to evaluate the factors associated with nephrotic syndrome remission in patient with nephrotic syndrome, biopsy-prove minimal change disease or focal segmental glomerulosclerosis, and an at-risk variant of the APOL1 gene.
As secondary objectives, this study aims:
* To evaluate the benefit of corticosteroids in obtaining the remission of nephrotic syndrome
* To identify the predictors of complete renal remission of nephrotic syndrome
* To evaluate the benefit of corticosteroids in reducing the incidence of end-stage renal disease
* To assess the adverse events of corticosteroids in patients treated with corticosteroids.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients followed in 6 nephrology centers between 01/01/2016 and 01/06/2024.
* With characterization of APOL1 gene risk status
* Proteinuria/creatinuria ratio \> 3 g/g at diagnosis of renal disease (within 48 hours of the diagnostic renal biopsy)
* Hypoalbuminemia \< 30 g/L at diagnosis of renal disease (within 48 h of diagnostic renal biopsy)
* Minimal change disease or segmental and focal hyalinosis lesions on renal biopsy.
Exclusion Criteria:
* Presence of diffuse deposits of immunoglobulins or complement fractions on immunofluorescence study
* Presence of endo- or extracapillary hypercellular lesions on light microscopy
* Opposition to the use of medical data
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.