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 range24 Months – 16 Years
SexALL
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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)
What they're measuring
1
Percentage of patients still in remission at 12 months after first flare of INS.