|- candidate number||1440|
|- NTR Number||NTR255|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||7-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Optimal treatment of steroid sensitive nephrotic syndrome in children.|
|- Scientific Title||Optimal treatment in children with the initial episode. |
|- hypothesis||Spreading the same cumulative dose of corticosteroids over a longer period of time will lower the number of patients with frequent relapses in steroid sensitive nephrotic syndrome in children.|
|- Healt Condition(s) or Problem(s) studied||Nephrotic syndrome, Minimal change nephrotic syndrome (MCNS), Idiopathic|
|- Inclusion criteria||1. Children from 9 months up to 16 years will be included;|
2. Only children with idiopathic nephrotic syndrome will be included.
|- Exclusion criteria||1. Children with nephrotic syndrome due to a specific disease;|
2. Children with more than five relapses;
3. Chilren younger than 9 month or older than 16 years.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2005|
|- planned closingdate||31-dec-2014|
|- Target number of participants||150|
|- Interventions||Prednisolone therapy.|
|- Primary outcome||Number of patients with frequent relapses.|
|- Secondary outcome||Number of patients with sustained remission.
Adverse effects of prednisolone.
Cumulative dose op prednisolone during follow up.
|- Trial web site||http://www.nefrotischsyndroom.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD N. Teeninga|
|- CONTACT for SCIENTIFIC QUERIES||MD N. Teeninga|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|[default], Dutch Kidney Foundation (Nierstichting Nederland)|
|- Brief summary||The aim of the study is to optimize treatment duration of corticosteroid therapy for steroid sensitive nephrotic syndrome (SSNS) in children.
Clinical outcome in terms of relapse rate and the occurrence of frequent relapses in SSNS seems to depend on the duration of initial corticosteroid treatment. In the Netherlands, standard treatment of the initial episode consists of 3 months corticosteroid therapy.
Hodson et al. published a Cochrane meta-analysis comprising all randomized controlled trials concerning treatment duration and dose of corticosteroids in the treatment of the nephrotic syndrome. This meta-analysis showed that clinical outcome is determined by treatment duration rather than dose. The number of patients with frequent relapses was found to be lower when treatment was prolonged from 2 to 3 months (OR 0.63, 95% CI 0.46-0.84).
In addition, the authors calculated that within a population with an expected relapse rate of 68% after two months of steroid treatment, the relapse rate will fall by 7.5% for every month by which the duration of therapy is prolonged. According to this calculation, further prolongation of the treatment from 3 to 6 months would reduce the expected relapse rate from 61% to 39%. However additional research was needed to confirm the benefit of 6 months versus 3 months corticosteroid therapy.
In a national multicentre, randomised, placebo controlled trial we will compare 6 months (24 weeks) versus 3 months (12 weeks) of corticosteroid therapy for the initial episode of idiopathic nephrotic syndrome. In both groups an equal cumulative dose of 3400 mg/m2 prednisolone is administered.
After a follow up period of 2, resp. 5 years, primary and secondary outcome will be evaluated in an intention-to-treat analysis. Power analysis regarding the primary outcome indicates that a decrease in the number of patients with frequent relapses from 72% to 48% will reach statistical significance with n=75 patients in each treatment group. The statistical analysis will be supported by the department of medical statistics of the Erasmus Medical Centre in Rotterdam. Scientific director is Dr. J. Nauta, head of the children’s nephrology department at the Sophia Children’s Hospital in Rotterdam.
|- Main changes (audit trail)||Updated on may 19th: main change: number of patients 150, used to be 340. |
Primary outcome now: Number of patients with frequent relapses. Used to be:
1. Number of patients in remission;
2. Number of relapses;
3. Number of patients with frequently relapsing nefrotic syndrome.
|- RECORD||7-sep-2005 - 26-okt-2011|