UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000732 |
|---|---|
| Receipt number | R000000880 |
| Scientific Title | Multicenter study of combination therapy using mizoribine, cyclosporin, basiliximab and steroids in kidney transplantation. |
| Date of disclosure of the study information | 2007/06/10 |
| Last modified on | 2015/01/07 15:06:43 |
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Basic information
Public title
Multicenter study of combination therapy using mizoribine, cyclosporin, basiliximab and steroids in kidney transplantation.
Acronym
Multicenter study of combination therapy using mizoribine, cyclosporin, basiliximab and steroids in kidney transplantation.
Scientific Title
Multicenter study of combination therapy using mizoribine, cyclosporin, basiliximab and steroids in kidney transplantation.
Scientific Title:Acronym
Multicenter study of combination therapy using mizoribine, cyclosporin, basiliximab and steroids in kidney transplantation.
Region
| Japan |
Condition
Condition
Kidney transplantation
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Compare the clinical outcome of mizoribine(MZ) and mycophenolate mofetil(MMF). We will perform the study of combination therapy in kidney transplantation, combined with MZ, cyclosporine(CyA), basiliximab and steroids, in compareson with historyical data with MMF, CyA, basiliximab and steroids.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of virus infection
Key secondary outcomes
Rejection reactions (incidence, types, severity), patient survival rate, graft suvival rate, incidence of adverse events / abnormalities in the laboratory values.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
cyclosporinbasiliximab + steroids + mizoribine
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.living donor kidney transplantation. 2.Gender free, any case of uremia. 3.Aged 2 years to 70 years. 4.ABO compatible (including semi-compatible)
The patient or whose family has submitted (if the patient is showing disturbance of consciousness or decreased ability to understand) written consent forms based on their free choice once adequate information and understandings are obtained regarding the study upon the participation.
Key exclusion criteria
1.The patient who has a history of hypersensitivity against components of either one of the following drugs: Bredinin tablet, Neoral or Simulect. 2.The patient who is pregnant or a female patient who is expecting to become pregnant. 3.The patients who showed a positive result with cross match test. 4.The patient who recived ABO incompatible donor. 5.The patient with whom the physician-in-charge considered inappropriate as a subject of this study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Hasegawa |
Organization
Toho University
Division name
School of Medicine
Zip code
Address
6-11-1 Omori-nishi Ota-ku,Tokyo,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
MNKT Forum
Division name
Keio University Department of Urolgy
Zip code
Address
TEL
03-5919-3825
Homepage URL
Sponsor or person
Institute
MNKT Forum
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2007 | Year | 06 | 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
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 | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | 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
| 2007 | Year | 06 | Month | 05 | Day |
Last modified on
| 2015 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000880
