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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009120
Receipt No. R000010695
Scientific Title A PROSPECTIVE, RANDOMIZED COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL IN COMBINATION THERAPY WITH TACROLIMUS AND BASILIXIMAB FOR LIVING DONOR RENAL TRANSPLANTATION.
Date of disclosure of the study information 2012/11/06
Last modified on 2014/12/26

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Basic information
Public title A PROSPECTIVE, RANDOMIZED COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL IN COMBINATION THERAPY WITH TACROLIMUS AND BASILIXIMAB FOR LIVING DONOR RENAL TRANSPLANTATION.
Acronym A COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL FOR LIVING DONOR RENAL TRANSPLANTATION.
Scientific Title A PROSPECTIVE, RANDOMIZED COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL IN COMBINATION THERAPY WITH TACROLIMUS AND BASILIXIMAB FOR LIVING DONOR RENAL TRANSPLANTATION.
Scientific Title:Acronym A COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL FOR LIVING DONOR RENAL 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, 12mg/kg/day) and mycophenolate mofetil (MMF, 2g/day). We will perform a prospective, randomized, comparative study of MZ versus MMF in combination therapy with tacrolimus, basiliximab and steroid for living donor kidney transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rejection (incidence, types, severity)
Key secondary outcomes Patient survival, graft survival, incidence of adverse effects / abnormalities in the laboratory values.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tacrolimus + basiliximab + steroid + mizoribine
Interventions/Control_2 Tacrolimus + basiliximab + steroid + cellcept
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Living donor kidney transplantation. 2.Primary kidney transplantation.
3.ABO blood type compatible (including semi-compatible).
4.Gender free, any case of uremia.
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 is pregnant or a female patient who is expecting to become pregnant.
2.The patient who has anti-donor antibody (anti-T antibody).
3.The patient who has severe infections.
5.The patient with whom the physician-in-charge considered inappropriate as a subject of this study.
Target sample size 120

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroshi Toma
Organization Tokyo Women Medical University
Division name professor
Zip code
Address 8-1, Kawadacho, Sinzyuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization AMCT
Division name Dep. Urology, Tokyo Women Medical University
Zip code
Address
TEL
Homepage URL https://www.statz.jp/aMcT200811/top.php
Email

Sponsor
Institute AMCT
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 仙台社会保険病院(宮城県)、東京女子医科大学(東京都)、虎ノ門病院(東京都)、
虎ノ門病院分院(神奈川県)、聖マリアンナ医科大学(神奈川県)、戸田中央総合病院(埼玉県)、新潟大学(新潟県)、大阪大学(大阪府)、大阪府立急性期・総合医療センター(大阪府)、大阪船員保険病院(大阪府)、兵庫県立西宮病院(兵庫県)、九州大学(福岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 06 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
2008 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 07 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 15 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=R000010695

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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