Mycophenolate in children with an idiopatic nephrotic syndrome.
| ISRCTN | ISRCTN86423228 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86423228 |
| Secondary identifying numbers | NTR502 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 06/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr E.M. Dorresteijn
Scientific
Scientific
Rijnland Hospital
Department of Pediatrics
P.O. Box 4220
Leiderdorp
2350 CC
Netherlands
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Other |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mycophenolate mofetil, cyclosporin A |
| Primary outcome measure | GFR |
| Secondary outcome measures | 1. Relapse rate 2. Other adverse effects |
| Overall study start date | 01/12/2002 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rijnland Hospital
Leiderdorp
2350 CC
Netherlands
2350 CC
Netherlands
Sponsor information
Rijnland Hospital (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 4220
Leiderdorp
2350 CC
Netherlands
"ROR" |
https://ror.org/05vc4qy60 |
|---|
Funders
Funder type
Industry
Roche Nederland BV (Netherlands)
No information available
Erasmus Medical Center (Netherlands)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
- Location
- Netherlands
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2008 | Yes | No |
