Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr N Rijswijk, van
ORCID ID
Contact details
Erasmus Medical Centre
Sophia Children's Hospital
Fellow pediatric nephrology
P.O Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4636588
n.vanrijswijk@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR255
Study information
Scientific title
Acronym
Study hypothesis
Spreading the same cumulative dose of corticosteroids over a longer period of time will lower the relapse rate in steroid sensitive nephrotic syndrome in children
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Minimal Change Nephrotic Syndrome(MCNS), Nephrotic syndrome
Intervention
Prednisolone therapy
Intervention type
Drug
Phase
Not Specified
Drug names
Prednisolone
Primary outcome measures
1. Number of patients in remission
2. Number of relapses
3. Number of patients with frequently relapsing nephrotic syndrome
Secondary outcome measures
Cumulative dose of prednisolon during follow up
Overall trial start date
01/01/2005
Overall trial end date
31/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children from 9 months up to 16 years will be included
2. Only children with idiopathic nephrotic syndrome will be included
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
340
Participant exclusion criteria
1. Children with nephrotic syndrome due to a specific disease
2. Children with more than five relapses
3. Children younger than 9 months or older than 16 years
Recruitment start date
01/01/2005
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre,
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636363
info@nierstichting.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Dutch Kidney Foundation (Nierstichting Nederland) (Netherlands)
Alternative name(s)
Dutch Kidney Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Netherlands
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