Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ML 16622
Study information
Scientific title
Acronym
Study hypothesis
Immunosuppressive therapy with mycophenolate mofetil (MMF) is as effective as cyclosporin A in preventing relapses of the nephrotic syndrome.
Ethics approval
Ethics approval received from the Ethics Committee of Charité - University Medicine Berlin (Germany) on the 2nd December 2002 (ref: 1656/Si 238).
Study design
Multicentre, randomised, open-labelled, cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Idiopathic nephrotic syndrome
Intervention
Immunosuppressive therapy with MMF versus cyclosporin A.
Intervention type
Drug
Phase
Not Specified
Drug names
Mycophenolate mofetil, cyclosporin A
Primary outcome measures
Number of relapses during the observation period
Secondary outcome measures
Decrease in GFR, hypertension and hyperlipidemia during the observation period
Overall trial start date
01/01/2004
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
55
Participant exclusion criteria
1. Other histological findings on renal biopsy
2. Other severe concomittant diseases
3. Decreased GFR
Recruitment start date
01/01/2004
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Augustenburger Platz 1
Berlin
13353
Germany
Sponsor information
Organisation
Hoffmann-La Roche AG (Germany)
Sponsor details
Emil-Barell-Strasse 1
Grenzach-Wyhlen
79639
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Hoffmann La Roche AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Charité - University Medicine Berlin (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
-
Results
Gellermann J, Querfeld U, Frequently relapsing nephrotic syndrome: treatment with mycophenolate mofetil., Pediatr. Nephrol., 2004, 19, 1, 101-104.