Contact information
Type
Scientific
Primary contact
Dr Karlien Cransberg
ORCID ID
Contact details
Erasmus Medical Center
Sophia Children's Hospital
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636363
k.cransberg@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR800
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised, multicentre parallel armed, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Nor ptovided at time of registration
Condition
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
Phase
Not Specified
Drug names
Mycophenolate mofetil (MMF), prednisolone and cyclosporin A (CsA)
Primary outcome measures
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 trial start date
01/01/2000
Overall trial end date
01/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
44
Participant 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
Recruitment start date
01/01/2000
Recruitment end date
01/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
Sponsor information
Organisation
Erasmus Medical Center (The Netherlands)
Sponsor details
Sophia Children's Hospital
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)
Alternative name(s)
Dutch Kidney Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Netherlands
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
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17452893
Publication citations
-
Results
Cransberg K, Cornelissen M, Lilien M, Van Hoeck K, Davin JC, Nauta J, Maintenance immunosuppression with mycophenolate mofetil and corticosteroids in pediatric kidney transplantation: temporary benefit but not without risk., Transplantation, 2007, 83, 8, 1041-1047, doi: 10.1097/01.tp.0000260146.57898.9c.