|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR800 |
|
Date of registration:
|
30/10/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Safety and efficacy of mycophenolate mofetil in pediatric renal transplantation.
|
|
Scientific title:
|
Maintenance immunosuppression with mycophenolate mofetil and corticosteroids in pediatric kidney transplantation. - N/A |
|
Date of first enrolment:
|
1/1/2000 |
|
Target sample size:
|
44 |
|
Recruitment status: |
complete |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=800 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
Karlien
Cransberg |
|
Address:
|
Erasmus Medical Center, Sophia Children's Hospital,
Dr Molewaterplein 60, Dr Molewaterplein 60
3015 GJ
Rotterdam
The Netherlands |
|
Telephone:
|
+31 (0)10 4636363 |
|
Email:
|
k.cransberg@erasmusmc.nl |
|
Affiliation:
|
|
|
|
Name:
|
Karlien
Cransberg |
|
Address:
|
Erasmus Medical Center, Sophia Children's Hospital,
Dr Molewaterplein 60, Dr Molewaterplein 60
3015 GJ
Rotterdam
The Netherlands |
|
Telephone:
|
+31 (0)10 4636363 |
|
Email:
|
k.cransberg@erasmusmc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: All Dutch children, receiving a first kidney transplant after 01-01-2000, treated with initial immunosuppression corticosteroids, MMF and CsA, during the latter part of the study with addition of basiliximab.
Exclusion criteria: 1. Not on triple therapy (Pred/CsA/MMF) at the end of the 1st year;
2. More than one acute rejection episode;
3. Rejection episode being not steroid sensitive;
4. No written informed consent.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Renal transplant
|
|
Intervention(s)
|
Start trial is one year after transplantation.
Randomisation between 2 groups:
continuing with MMF/Pred or CsA/Pred by withdrawal over 3 months of the 3rd immunosuppressive drug. During the 3 months of withdrawal the Predniolone dosage is doubled. Follow-up is 2 years.
|
|
Primary Outcome(s)
|
1. Glomerular filtration rate;
2. Incidence of acute rejections;
3. Serumlipids;
4. Bloodpressure and number of antihypertensive drugs.
|
|
Secondary Outcome(s)
|
1. Graft survival;
2. Incidence of malignancies;
3. Incidence of viral infections;
4. Incidence of anemia.
|
|
Secondary ID(s)
|
|
ISRCTN89278733
|
|
N/A
|
|
Source(s) of Monetary Support
|
|
Dutch Kidney Foundation (Nierstichting Nederland)
|
|