evamisole treatment for children with steroid sensitive nephrotic syndrome.
Recruiting
- Conditions
- steroid sensitive idiopathic nephrotic syndrome(steroid gevoelig idiopathisch nefrotisch syndroom), relapse (recidief), levamisole, steroid side effects (steroid bijwerkingen),
- Registration Number
- NL-OMON26305
- Lead Sponsor
- Academic Medical Center of AmsterdamMeibergdreef 9, 1105 AZ Amsterdam Z-OThe Netherlands
- Brief Summary
Davin JC, Merkus MP. - Levamisole in steroid-sensitive nephrotic syndrome of childhood: the lost paradise? Pediatr Nephrol. 2005 Jan;20(1):10-4.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Primary diagnosis: frequently relapsing idiopathic Steroid Sensitive Nephrotic Syndrome with or without steroid dependency;
2. 2 > Age < 18 years;
Exclusion Criteria
1. Patients previously treated with Levamisole;
2. Patients unresponsive to Cyclosporine or MMF;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is defined as the time to relapse which is the 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.<br>Proposed end of the blinded part of the study is in all patients 12 months after start of the study medication.
- Secondary Outcome Measures
Name Time Method 1. Average quantity in milligrams of steroids administered per month during the study;<br /><br>2. Evaluation whether treatment effect differs with underlying disease process (steroid dependency yes/no) and prior use of disease modifying agents (yes/no);<br /><br>3. Maintenance dose prednisone at time of relapse.