Mycophenolate in children with an idiopatic nephrotic syndrome.

ISRCTN	ISRCTN86423228
DOI	https://doi.org/10.1186/ISRCTN86423228
Protocol serial number	NTR502
Sponsor	Rijnland Hospital (Netherlands)
Funders	Roche Nederland BV (Netherlands), Erasmus Medical Center (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr E.M. Dorresteijn
Scientific

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

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised multi-centre study comparing mycophenolate and cyclosporin A in children with a frequent relapsing or corticoid dependent idiopathic nephrotic syndrome
Study objectives	Mycophenolate mofetil is effective in preventing relapses of nephrotic syndrome and has less nephrotoxic effects compared to cyclosporin A.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Nephrotic syndrome
Intervention	Randomisation for mycophenolate or cyclosporin A.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Mycophenolate mofetil, cyclosporin A
Primary outcome measure(s)	GFR
Key secondary outcome measure(s)	1. Relapse rate 2. Other adverse effects
Completion date	01/06/2005

Participant type(s)	Patient
Age group	Child
Upper age limit	18 Years
Sex	All
Target sample size at registration	31
Key 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
Key exclusion criteria	1. Severe anemia or leucopenia 2. Active infection 3. Failure of cyclosporin treatment in history
Date of first enrolment	01/12/2002
Date of final enrolment	01/06/2005

Rijnland Hospital

Leiderdorp
2350 CC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2008		Yes	No