Levamisole treatment for children with steroid sensitive nephrotic syndrome
| ISRCTN | ISRCTN23853712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23853712 |
| Protocol serial number | ACE080503 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funders | Dutch Kidney Foundation (Netherlands) (ref: C04.2116), Emma Children's Hospital Foundation (Netherlands), Foundation Rare Diseases Fund ((Netherlands) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Academic Medical Centre (AMC)
Emma Kinderziekenhuis
Department of Paediatric Nephrology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 7919 |
|---|---|
| j.c.davin@amc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre double-blind placebo-controlled randomised clinical trial followed by a cohort study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levamisole |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Average quantity in milligrams of steroids administered per month during the study, measured 12 months after randomisation |
| Completion date | 28/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| 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
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/01/2019: Publication reference added
