Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT02997150
Eligibility Criteria:
Inclusion Criteria:
* Children between 3 and 15 years of age (included) with a steroid responsive idiopathic nephrotic syndrome
* Idiopathic nephrotic syndrome progressing for less than 1 year
* Steroid dependent idiopathic nephrotic syndrome (at least 1 relapse when steroids are tapered off or within 3 months after their withdrawal, and reliance on steroids \> 15 mg/m² every other day)
* Steroid dose at inclusion between 15 and 60 mg/m²every other day
* Patient with a stable dose of steroids within the 8 days before and after the first injection of IL2
* Patient in remission for more than 15 days
* Patient affiliated to a French health insurance
* Signed consent of parental authority
Exclusion Criteria:
* Hypersensitivity to IL2 or to one of its excipients
* Significant history or presence of cardiopathy
* Signs of evolving infection requiring an antibiotic treatment
* Respiratory distress, respiratory infection or chronic respiratory failure
* Serious dysfunction of one of the vital organs
* Leukocytes \< 4000/mm3 ; platelets \< 100 000/mm3; hematocrit \<30%
* Anomaly of serum bilirubin and creatinin levels
* History of organ allograft
* Other pre-existing autoimmune disease
* Male and female pubescent teenagers under the age of 15
* Male and female teenagers whose puberty has begun for more than one year
* Asthmatic patient
* Pregnant or breastfeeding female patient
* Participation in another therapeutic trial concurrently or 30 days prior to inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
15 Years
Study:
NCT02997150
Study Brief:
Protocol Section:
NCT02997150