Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jean-Claude Davin
ORCID ID
Contact details
Academic Medical Centre (AMC)
Emma Kinderziekenhuis
Department of Paediatric Nephrology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7919
j.c.davin@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ACE080503
Study information
Scientific title
Levamisole treatment for children with steroid sensitive nephrotic syndrome: a multicentre double-blind placebo-controlled randomised trial
Acronym
Study hypothesis
Levamisole prevents the occurence of relapses of nephrotic syndrome and prolongs the time to a relapse in children with frequent relapsing steroid sensitive nephrotic syndrome (SSNS).
Please note that as of 18/02/2013, the anticipated end date for this trial was updated from 15/05/2010 to 28/03/2012
Ethics approval
Medical Ethics Committee of Academic Medical Centre Amsterdam approved on the 6th April 2006
Study design
Multicentre double-blind placebo-controlled randomised clinical trial followed by a cohort study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nephrotic syndrome
Intervention
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 dose of 2.5 mg/kg on alternate days. In the RCT, the start of levamisole/placebo treatment is considered day 0, treatment will be discontinued when a relapse, necessitating prednisone treatment occurs or after 12 months. Patients who have a premature withdrawal (relapse) will be followed up for the whole period of 12 months. In the cohort study levamisole treatment will be continued for 12 months unless patients will have more than one relapse in 6 months.
Intervention type
Drug
Phase
Not Applicable
Drug names
Levamisole
Primary outcome measures
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
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
Overall trial start date
15/05/2007
Overall trial end date
28/03/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100: 50 placebo, 50 levamisole
Participant 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
Recruitment start date
15/05/2007
Recruitment end date
28/03/2012
Locations
Countries of recruitment
Belgium, France, India, Italy, Netherlands, Poland
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Emma Kinderziekenhuis
Department of Paediatric Nephrology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 7919
levamisol@amc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Dutch Kidney Foundation (Netherlands) (ref: C04.2116)
Alternative name(s)
Dutch Kidney Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Netherlands
Funder name
Emma Children's Hospital Foundation (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation Rare Diseases Fund ((Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary