Efficiency of Levamisole for Maintaining Remission After the First Flare of Steroid Sensitive Nep… (NCT02818738) | Clinical Trial Compass
CompletedPhase 3
Efficiency of Levamisole for Maintaining Remission After the First Flare of Steroid Sensitive Nephrotic Syndrome in Children
France86 participantsStarted 2017-09-06
Plain-language summary
Idiopathic Nephrotic Syndrome is sensitive to steroid in 90% of children. However, most patients relapse and become steroid-dependant, with a long lasting relapsing course. The aim of this study is to assess the efficiency of a 6-months levamisole course, given early after first remission, on maintaining a relapse-free course at 12 months.
Who can participate
Age range
24 Months – 16 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:
* Age 24 months \< age \< 16 years
* Diagnosis of first manifestation of INS defined by:
* hypoalbuminemia \< 25g/l, proteinuria \> 0.20 g/mmol of urinary creatinine
* normal C3 fraction of complement
* Use of mechanical contraception for patients of reproductive age throughout the research period
* Beneficiary of a social protection scheme (except AME)
* Written informed consent from one of both parents
* Ability to realise follow-up in full
Exclusion Criteria:
* Anteriority of INS
* Pregnancy, breast feeding or planned pregnancy during the study
* Malignant pathology (antecedent or ongoing), diabetes, liver disease
* Hypersensitivity to levamisole or its excipients (lactose)
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.
What they're measuring
1
Percentage of patients still in remission at 12 months after first flare of INS.