Levamisole treatment for children with steroid sensitive nephrotic syndrome

ISRCTN	ISRCTN23853712
DOI	https://doi.org/10.1186/ISRCTN23853712
Secondary identifying numbers	ACE080503

Submission date: 19/05/2009
Registration date: 18/09/2009
Last edited: 18/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Jean-Claude Davin
Scientific

Academic Medical Centre (AMC)
Emma Kinderziekenhuis
Department of Paediatric Nephrology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 7919
Email	j.c.davin@amc.nl

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Levamisole treatment for children with steroid sensitive nephrotic syndrome: a multicentre double-blind placebo-controlled randomised trial
Study objectives	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(s)	Medical Ethics Committee of Academic Medical Centre Amsterdam approved on the 6th April 2006
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Levamisole
Primary outcome measure	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 study start date	15/05/2007
Completion date	28/03/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	18 Years
Sex	Both
Target number of participants	100: 50 placebo, 50 levamisole
Key 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
Key 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
Date of first enrolment	15/05/2007
Date of final enrolment	28/03/2012

Locations

Countries of recruitment

Belgium
France
India
Italy
Netherlands
Poland

Study participating centre

Academic Medical Centre (AMC)

Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre

Emma Kinderziekenhuis
Department of Paediatric Nephrology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 7919
Email	levamisol@amc.nl
Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Charity

Dutch Kidney Foundation (Netherlands) (ref: C04.2116)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Dutch Kidney Foundation
Location: Netherlands

Emma Children's Hospital Foundation (Netherlands)

No information available

Foundation Rare Diseases Fund ((Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2018	18/01/2019	Yes	No

Editorial Notes

18/01/2019: Publication reference added