Prevention of the return of nephrotic syndrome in children by adding levamisole to standard prednisone treatment. Het voorkomen van terugval van het nefrotisch syndroom bij kinderen door het toevoegen van levamisol aan de standaardbehandelng met prednison.
Recruiting
- Conditions
- Idiopathic nephrotic syndrome / Idiopathisch nefrotisch syndroomRelapse / RecidiefChilderen / KinderenLevamisole / Kinderen
- Registration Number
- NL-OMON27331
- Lead Sponsor
- Academic Medical Center (AMC)Postbus 22600 1100 DD AmsterdamThe Netherlands+31 (0)20 566 9111
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 92
Inclusion Criteria
Inclusion criteria for Immunomics/Biobank:
- Age 2 to 16 years.
Exclusion Criteria
Exclusion criteria for Immunomics/Biobank:
- Age <2 years or >16 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Time to first relapse.<br /><br>- Relapse rate (number of relapses per person per year) over 2-year period after first presentation. <br /><br> Cumulative steroid dose over 2-year period.<br /><br>- Occurrence of adverse events and treatment discontinuation.<br /><br>- Proportion of frequent relapsing or steroid dependent nephrotic syndrome over 2-year period. <br /><br>- 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. <br /><br>- 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. <br /><br>- Days of school missing, outpatient visits, and hospitalisation days (macro-economic analysis). <br /><br>- Number of treatment interruptions. <br>