Interleukin 2, Nephrotic Syndrome Steroid-Dependent
Conditions
Keywords
Idiopathic nephrotic syndrome-child-steroid dependant-IL2, Safety, Efficacy
Brief summary
NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy via an increased production of regulatory T cells.
Detailed description
The study will include 10 children (age: 3-15 years old). Patients will receive low doses of Interleukin 2 (0.5 million UI/m²/ injection, subcutaneously). The treatment will be initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months.
Interventions
DRUGIL-2 Low dose
Patients receive low doses of Interleukin 2: 0.5 million UI/m²/ injection subcutaneously. The treatment is initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months. At the same time, corticoid treatment will be tapered until its complete withdrawal no later than 3 months from the first injection
Sponsors
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of success: absence of relapse of idiopathic nephrotic syndrome | Day 184 | Absence of relapse of idiopathic nephrotic syndrome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Interleukin-2 | Day 214 | Study of adverse events |
| Increase of regulatory T cells after 5 injections of Interleukin-2 | Day 8 | increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to fifth injection, expressed as a percentage |
| Increase of regulatory T cells after 18 injections of Interleukin-2 | Day 184 | increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to eighteenth injection, expressed as a percentage |
Outcome results
None listed