Condition category
Urological and Genital Diseases
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E.M. Dorresteijn

ORCID ID

Contact details

Rijnland Hospital
Department of Pediatrics
P.O. Box 4220
Leiderdorp
2350 CC
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR502

Study information

Scientific title

Randomised multi-centre study comparing mycophenolate and cyclosporin A in children with a frequent relapsing or corticoid dependent idiopathic nephrotic syndrome

Acronym

Study hypothesis

Mycophenolate mofetil is effective in preventing relapses of nephrotic syndrome and has less nephrotoxic effects compared to cyclosporin A.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Other

Patient information sheet

Condition

Nephrotic syndrome

Intervention

Randomisation for mycophenolate or cyclosporin A.

Intervention type

Drug

Phase

Not Specified

Drug names

Mycophenolate mofetil, cyclosporin A

Primary outcome measures

GFR

Secondary outcome measures

1. Relapse rate
2. Other adverse effects

Overall trial start date

01/12/2002

Overall trial end date

01/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children <18 years
2. Minimal change nephrotic syndrome
3. Glomerular filtration rate (GFR) >80 ml/1.73 m2/min
4. Steroid dependency or frequent relapsing

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

31

Participant exclusion criteria

1. Severe anemia or leucopenia
2. Active infection
3. Failure of cyclosporin treatment in history

Recruitment start date

01/12/2002

Recruitment end date

01/06/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Rijnland Hospital
Leiderdorp
2350 CC
Netherlands

Sponsor information

Organisation

Rijnland Hospital (Netherlands)

Sponsor details

P.O. Box 4220
Leiderdorp
2350 CC
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Roche Nederland BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Erasmus Medical Center (Netherlands)

Alternative name(s)

Erasmus Medical Center, Erasmus MC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18622632

Publication citations

  1. Results

    Dorresteijn EM, Kist-van Holthe JE, Levtchenko EN, Nauta J, Hop WC, van der Heijden AJ, Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome., Pediatr. Nephrol., 2008, 23, 11, 2013-2020, doi: 10.1007/s00467-008-0899-6.

Additional files

Editorial Notes