evamisole treatment for children with steroid sensitive nephrotic syndrome

Not Applicable

Completed

• Conditions: ephrotic syndrome; Urological and Genital Diseases; Nephrotic syndrome

• Registration Number: ISRCTN23853712
• Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29054532 (added 18/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-18
• Study Completion: 2012-03-28
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Average quantity in milligrams of steroids administered per month during the study, measured 12 months after randomisation<br> 2. Evaluation whether treatment effect differs with underlying disease process (steroid dependency yes/no), measured 12 months after randomisation<br> 3. Prior use of disease modifying agents (yes/no), measured 12 months after randomisation<br> 4. Maintenance dose prednisone at time of relapse, reported at time of relapse<br>