UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008649 |
|---|---|
| Receipt number | R000010165 |
| Scientific Title | Efficacy of Mizoribine (MZR) treatment for gastrointestinal symptoms in kidney transplant recipients using mycophenolate mofetil (MMF). - Open-label, multicenter, randomized, controlled trial – |
| Date of disclosure of the study information | 2012/08/08 |
| Last modified on | 2014/12/26 16:53:26 |
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Basic information
Public title
Efficacy of Mizoribine (MZR) treatment for gastrointestinal symptoms in kidney transplant recipients using mycophenolate mofetil (MMF).
- Open-label, multicenter, randomized, controlled trial –
Acronym
Mizoribine Convert Study
Scientific Title
Efficacy of Mizoribine (MZR) treatment for gastrointestinal symptoms in kidney transplant recipients using mycophenolate mofetil (MMF).
- Open-label, multicenter, randomized, controlled trial –
Scientific Title:Acronym
Mizoribine Convert Study
Region
| Japan |
Condition
Condition
Kidney transplantation
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Divide kidney transplant patients who have gastrointestinal symptoms due to MMF into two treatment groups; one group switches to MZR, another continues MMF.
Compare the QOL in both groups using Gastrointestinal Symptom Rating Scale SF-8 and examine the efficacy of MZR.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of GSRS results between the 1st day and a month later.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
mizoribine
Interventions/Control_2
mycophenolate mofetil
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Conduct a GSRS survey during MMF treatment, and patients included if GSRS score 3 (on a scale of 1 to 7) applies to more than 2 items, or GSRS score 4 applies to at least one of the following: (1):Abdominal pain, (2):Heartburn, (10):Decreased passage of stools, (11):Increased passage of stools, (12):Loose stools, (14):Urgent need for defecation.
Patients who had a detailed briefing of the trial with explanatory documents prior to the enrollment, and voluntarily signed a consent form.
Key exclusion criteria
1. currently undergoing acute rejection
2. positive for DSA
3. serum creatinine level of less than 3mg/dL
4. a severe infection other than viral infection
5. white blood cell counts of less than 3,000/mm3
6. pregnant women and women suspected of being pregnant
7. aged 19 or younger
8. considered inappropriate by the doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Tanabe |
Organization
Tokyo Women Medical University
Division name
Dep. Urology
Zip code
Address
8-1, Kawadacho, Sinzyuku-ku, Tokyo, Japan
TEL
03-3353-8111
tgphide@gol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ishida |
Organization
Tokyo Women Medical University
Division name
Dep. Urology
Zip code
Address
TWMU
TEL
03-3353-8111
Homepage URL
hishida@kc.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women Medical University,
Dep. Urology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 08 | Month | 08 | 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
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
| 2012 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 08 | Day |
Last modified on
| 2014 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010165
