Safety and efficacy of mycophenolate mofetil in pediatric renal transplantation
| ISRCTN | ISRCTN89278733 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89278733 |
| Secondary identifying numbers | NTR800 |
- Submission date
- 01/12/2006
- Registration date
- 01/12/2006
- Last edited
- 03/01/2008
- 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 Karlien Cransberg
Scientific
Scientific
Erasmus Medical Center
Sophia Children's Hospital
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636363 |
|---|---|
| k.cransberg@erasmusmc.nl |
Study information
| Study design | Randomised, multicentre parallel armed, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Nor ptovided at time of registration |
| Scientific title | |
| Study objectives | 1. Mycophenolate Mofetil (MMF)/prednisolone is as efficacious in prevention of acute rejections as Cyclosporin A (CsA)/prednisolone 2. MMF/prednisolone is safer than CsA/prednisolone, in renal function, lipids, and blood pressure |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Renal transplant |
| Intervention | Start trial is one year after transplantation. Randomisation between two groups: continuing with MMF/prednisolone or CsA/prednisolone by withdrawal over three months of the third immunosuppressive drug. During the three months of withdrawal, the prednisolone dosage is doubled. Follow-up is two years. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mycophenolate mofetil (MMF), prednisolone and cyclosporin A (CsA) |
| Primary outcome measure | 1. Glomerular filtration rate 2. Incidence of acute rejections 3. Serum lipids 4. Blood pressure and number of antihypertensive drugs |
| Secondary outcome measures | 1. Graft survival 2. Incidence of malignancies 3. Incidence of viral infections 4. Incidence of anemia |
| Overall study start date | 01/01/2000 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | 44 |
| Key inclusion criteria | 1. All Dutch children, receiving a first kidney transplant after 01/01/2000 2. Treated with initial immunosuppression corticosteroids, MMF and CsA, during the latter part of the study with addition of basiliximab |
| Key exclusion criteria | 1. Not on triple therapy (prednisolone/CsA/MMF) at the end of the first year 2. More than one acute rejection episode 3. Rejection episode being not steroid sensitive 4. No written informed consent |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Sophia Children's Hospital
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Charity
Dutch Kidney Foundation (Nierstichting Nederland) (The 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 27/04/2007 | Yes | No |
