UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016764 |
|---|---|
| Receipt number | R000019452 |
| Scientific Title | Pharmacokinetic Study of mycophenolate mofetil combined with rituximab in patients with Childhood-onset Complicated Frequently Relapsing or Steroid-dependent Nephrotic Syndrome |
| Date of disclosure of the study information | 2015/03/10 |
| Last modified on | 2025/04/03 11:21:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pharmacokinetic Study of mycophenolate mofetil combined with rituximab in patients with Childhood-onset Complicated Frequently Relapsing or Steroid-dependent Nephrotic Syndrome
Acronym
Pharmacokinetic Study of MMF(JSKDC09)
Scientific Title
Pharmacokinetic Study of mycophenolate mofetil combined with rituximab in patients with Childhood-onset Complicated Frequently Relapsing or Steroid-dependent Nephrotic Syndrome
Scientific Title:Acronym
Pharmacokinetic Study of MMF(JSKDC09)
Region
| Japan |
Condition
Condition
Childhood-onset Complicated Frequently Relapsing or Steroid-dependent Nephrotic Syndrome
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to determine the pharmacokinetics of MMF in combination with rituximab in patients with Childhood-onset Complicated Frequently Relapsing or Steroid-dependent Nephrotic Syndrome
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics parameters of MPA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The measurement of the concentration of MPA
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who enrolled in Mycophenolate mofetil for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind,randomised, placebo-controlled trial(JSKDC07)
2. Subjects have ability to provide written informed consent form. The written informed consent form of legal representative (i.e., a parent or a legal benefactor) is also required for subjects less than 20 years of age
Key exclusion criteria
1. Judged inappropriate for this study by the physicians
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazumoto |
| Middle name | |
| Last name | Iijima |
Organization
Division of Child Health and Development
Kobe University Graduate School of medicine
Division name
Department of Pediatrics
Zip code
650-0017
Address
5-1 Kusunoki-cho 7 chome
TEL
078-382-6093
iijima@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Sako |
Organization
National Center for Child Health and Development
Division name
Division for Clinical Trials
Zip code
157-8535
Address
2-10-1 Ookura, Setagaya-ku, TOKYO
TEL
03-3416-0181
Homepage URL
sako-m@ncchd.go.jp
Sponsor or person
Institute
Japanese Study Group of Kidney Disease in Children
Institute
Department
Personal name
Funding Source
Organization
AEMD
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
Kobe University Clinical Research Ethical Committee
Address
5-1 Kusunoki-cho 7 chome
Tel
078-382-6669
cerb@med.kobe-u.ac.jp
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
| 2015 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
79
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
| 2015 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 10 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019452
