Idiopathic nephrotic syndrome / Idiopathisch nefrotisch syndroom Relapse / Recidief Childeren / Kinderen Levamisole / Kinderen
Conditions
Interventions
- Prednisolone schedule according to French protocol: tapering schedule of 18 weeks (in comparison to 12 weeks of prednisolone according to Dutch protocol 'Werkboek Kindernefrologie').
- Additional
Sponsors
Academic Medical Center (AMC)
Postbus 22600
1100 DD Amsterdam
The Netherlands
+31 (0)20 566 9111
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for Immunomics/Biobank: - Age 2 to 16 years. - First episode of idiopathic nephrotic syndrome, confirmed by: hypoalbuminaemia 200 mg/mmol creatinine; Complement C3 within normal range. - Written informed consent. Inclusion criteria for RCT: - Steroid sensitive nephrotic syndrome (remission achieved after 4 weeks of oral treatment with prednisolone). - Weight >9 kg - Ability to swallow (placebo) 5 mg tablet of study medication in children <6 years of age. - Negative pregnancy test in girls who are of childbearing potential. - Absence of contraindication for levamisole: neutropenia <1500/mm3. - Ability to comply to study protocol.
Exclusion criteria
Exclusion criteria: Exclusion criteria for Immunomics/Biobank: - Age 16 years. - Previous episodes of INS. Exclusion criteria for RCT: - Steroid resistant nephrotic syndrome (persistent proteinuria after 4 weeks of oral treatment with prednisolone). - Previous or current malginancy, diabetes mellitus type 1, current liver disease, and/or convulsions. - Hypersensitivity to levamisole or one of its substances (lactose).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of relapse within 12 months after first presentation. Relapse is defined as the recurrence of proteinuria (3+ urine dipstick or >200 mg/mmol creatinine) on three consecutive days. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to first relapse. - Relapse rate (number of relapses per person per year) over 2-year period after first presentation. Cumulative steroid dose over 2-year period. - Occurrence of adverse events and treatment discontinuation. - Proportion of frequent relapsing or steroid dependent nephrotic syndrome over 2-year period. - Toxicity of corticosteroids: difference in BMI, blood pressure, height, weight, and serum glucose between groups; Proportion of patients with overweight (BMI >25 kg/m2), hypertension (p>90), and hyperglycaemia. - Toxicity of levamisole: Proportion of patients with elevated (>3 times upper limit of normal) of liver enzymes (ALAT, ASAT, gamma-GT, bilirubin), neutropenia (<1500/mm3), and/or positive ANCA. - Days of school missing, outpatient visits, and hospitalisation days (macro-economic analysis). - Number of treatment interruptions. | — |
Contacts
Public ContactF. Veltkamp
Acedemic Medical Center (AMC)
Outcome results
None listed