UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study on the efficacy and safety of pharmacokinetics of mycophenolate mofetil for pediatric renal transplantation
Title of the study (Brief title)	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	Kazumoto Iijima
Organization	Kobe University Hospital
Division name	Department of Pediatrics
Address	5-2 Kusunoki-cho 7 chome,Kobe
TEL	078-382-6093
Email	iijima@med.kobe-u.ac.jp

Public contact
Name of contact person	Mayumi Sako
Organization	National Center for Child Health and Development
Division name	Department of Nephrology
Address	2-10-1 Okura Setagaya-ku, Tokyo
TEL	03-3416-0181
Homepage URL
Email	sako-m@ncchd.go.jp

Sponsor
Institute	Japanese Study group of Pediatric Renal Transplantation
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 11 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000659