Condition category
Urological and Genital Diseases
Date applied
19/05/2009
Date assigned
18/09/2009
Last edited
18/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.levamisoletrial.com/

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes