Condition category
Urological and Genital Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
25/08/2009
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.nefrotischsyndroom.nl

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

Publication citations

Additional files

Editorial Notes