Optimal treatment of steroid sensitive nephrotic syndrome in children
| ISRCTN | ISRCTN27871415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27871415 |
| Secondary identifying numbers | NTR255 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 25/08/2009
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr N Rijswijk, van
Scientific
Scientific
Erasmus Medical Centre
Sophia Children's Hospital
Fellow pediatric nephrology
P.O Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 4636588 |
|---|---|
| n.vanrijswijk@erasmusmc.nl |
Study information
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Spreading the same cumulative dose of corticosteroids over a longer period of time will lower the relapse rate in steroid sensitive nephrotic syndrome in children |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Minimal Change Nephrotic Syndrome(MCNS), Nephrotic syndrome |
| Intervention | Prednisolone therapy |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prednisolone |
| Primary outcome measure | 1. Number of patients in remission 2. Number of relapses 3. Number of patients with frequently relapsing nephrotic syndrome |
| Secondary outcome measures | Cumulative dose of prednisolon during follow up |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 9 Months |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 340 |
| Key inclusion criteria | 1. Children from 9 months up to 16 years will be included 2. Only children with idiopathic nephrotic syndrome will be included |
| Key exclusion criteria | 1. Children with nephrotic syndrome due to a specific disease 2. Children with more than five relapses 3. Children younger than 9 months or older than 16 years |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre,
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636363 |
|---|---|
| info@nierstichting.nl | |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Charity
Dutch Kidney Foundation (Nierstichting Nederland) (Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Dutch Kidney Foundation
- 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 |
