Therapy of frequent relapsing, steroid-sensitive nephrotic syndrome in childhood: efficacy of mycophenolate mofetil versus cyclosporin A

ISRCTN	ISRCTN61976169
DOI	https://doi.org/10.1186/ISRCTN61976169
Secondary identifying numbers	ML 16622

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Jutta Gellermann
Scientific

Augustenburger Platz 1
Berlin
13353
Germany

Study design	Multicentre, randomised, open-labelled, cross-over trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Immunosuppressive therapy with mycophenolate mofetil (MMF) is as effective as cyclosporin A in preventing relapses of the nephrotic syndrome.
Ethics approval(s)	Ethics approval received from the Ethics Committee of Charité - University Medicine Berlin (Germany) on the 2nd December 2002 (ref: 1656/Si 238).
Health condition(s) or problem(s) studied	Idiopathic nephrotic syndrome
Intervention	Immunosuppressive therapy with MMF versus cyclosporin A.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Mycophenolate mofetil, cyclosporin A
Primary outcome measure	Number of relapses during the observation period
Secondary outcome measures	Decrease in GFR, hypertension and hyperlipidemia during the observation period
Overall study start date	01/01/2004
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	17 Years
Sex	Both
Target number of participants	55
Key inclusion criteria	1. Children aged 3 - 17 years 2. Frequent relapses of steroid-sensitive nephrotic syndrome, associated with minimal changes on renal biopsy 3. Glomerular Filtration Rate (GFR) greater than 70 ml/min
Key exclusion criteria	1. Other histological findings on renal biopsy 2. Other severe concomittant diseases 3. Decreased GFR
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2008

Augustenburger Platz 1

Berlin
13353
Germany

Hoffmann-La Roche AG (Germany)
Industry

Emil-Barell-Strasse 1
Grenzach-Wyhlen
79639
Germany

Website	http://www.roche.de
"ROR"	https://ror.org/00sh68184

Industry

Hoffmann La Roche AG (Germany)

No information available

Charité - University Medicine Berlin (Germany)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/01/2004		Yes	No