Nephrotic syndrome Urological and Genital Diseases Nephrotic syndrome
Conditions
Interventions
Treatment with levamisole/placebo will be started during prednisone treatment for relapse when patient's urine is protein free for 3 to 21 days. Levamisole/placebo will be given orally as tablet in a
Sponsors
Academic Medical Centre (AMC) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary diagnosis: frequently relapsing idiopathic SSNS with or without steroid dependency 2. Aged less than or equal to 18 years (not less than two years), either sex 3. Written Informed Consent
Exclusion criteria
Exclusion criteria: 1. Previously treated with Levamisole 2. Unresponsive to cyclosporine or mycophenolate mofetil (MMF) 3. Nephrotic syndrome due to specific kidney diseases 4. Patients with neutropenia, convulsions and hepatic disease 5. Patients with prolongation of the QTc-time on the surface electrocardiogram (greater than 0.44 secconds) 6. Pregnancy, breast-feeding or planned pregnancy during the study 7. Participation in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to relapse; time between start of the study medication and occurrence of a relapse or, in case of no relapse, time of censoring (12 months after start of trial medication). Only a relapse necessitating prednisone treatment is considered a primary endpoint relapse. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Average quantity in milligrams of steroids administered per month during the study, measured 12 months after randomisation 2. Evaluation whether treatment effect differs with underlying disease process (steroid dependency yes/no), measured 12 months after randomisation 3. Prior use of disease modifying agents (yes/no), measured 12 months after randomisation 4. Maintenance dose prednisone at time of relapse, reported at time of relapse | — |
Countries
Belgium, France, India, Italy, Netherlands, Poland
Outcome results
None listed