UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000541 |
|---|---|
| Receipt number | R000000659 |
| Scientific Title | The study on the efficacy and safety of pharmacokinetics of mycophenolate mofetil for pediatric renal transplantation |
| Date of disclosure of the study information | 2007/01/05 |
| Last modified on | 2016/08/19 09:45:10 |
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Basic information
Public title
The study on the efficacy and safety of pharmacokinetics of mycophenolate mofetil for pediatric renal transplantation
Acronym
Mycophenolate mofetil for pediatric renal transplantation
Scientific Title
The study on the efficacy and safety of pharmacokinetics of mycophenolate mofetil for pediatric renal transplantation
Scientific Title:Acronym
Mycophenolate mofetil for pediatric renal transplantation
Region
| Japan |
Condition
Condition
pediatric renal transplantation
Classification by specialty
| Nephrology | Pediatrics | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the efficacy and safety of Mycophenolate mofetil for prevention of acute rejection in pediatric renal allograft recipients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the proportion of patients experiencing a rejection episode within the first 6 months post-transplantation
Key secondary outcomes
1.the proportion of patients who kept their graft by 12 months post-transplantation.
2.the proportion of patients who lived at 12 months post-transplantation.
3.the proportion of patients experiencing
a biopsy-proven rejection episode at 12
months post-transplantation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Mycophenolate mofetil
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Recipients of a first kidney allograft from a living or cadaver donor
2. Patients under the age of 20
3.Written informed consent from the patients' parents or legal guardians
4. Patients who are able to go to hospital during therapy of the trial
Key exclusion criteria
1. The acute rejection after renal transplantation.
2. Use ofimmunosuppressant which works the same way as MMF does.
3. Prior exposure to live vaccine within one month before the treatment of MMF
4. Active peptic ulcer disease
5. Severe liver dysfunction
6. Leucopenia at study entry
7. Active systemic infection
8. Malignancy
9. Hemorrhagic diathesis
10. Refractory diarrhea
11. Medical history of severe allergy or
drug hypersensitivity
12. ABO-incompatible kidney allograft
13. Anti-donor antibody positive patients
14. Pregnancy
15. Judged inappropriate for this study by the physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumoto Iijima |
Organization
Kobe University Hospital
Division name
Department of Pediatrics
Zip code
Address
5-2 Kusunoki-cho 7 chome,Kobe
TEL
078-382-6093
iijima@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Sako |
Organization
National Center for Child Health and Development
Division name
Department of Nephrology
Zip code
Address
2-10-1 Okura Setagaya-ku, Tokyo
TEL
03-3416-0181
Homepage URL
sako-m@ncchd.go.jp
Sponsor or person
Institute
Japanese Study group of Pediatric Renal Transplantation
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 06 | Day |
Last modified on
| 2016 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000659
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
