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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008649
Receipt No. 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

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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
Email 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
Email hishida@kc.twmu.ac.jp

Sponsor
Institute Tokyo Women Medical University,
Dep. Urology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010165

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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