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
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
-
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.