UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter study of combination therapy using calcineurin inhibitor, basiliximab, mizoribine and steroids in kidney transplantation.
Acronym	Multi-drug combination therapy in kidney transplantation.
Scientific Title	Multicenter study of combination therapy using calcineurin inhibitor, basiliximab, mizoribine and steroids in kidney transplantation.
Scientific Title:Acronym	Multi-drug combination therapy in kidney transplantation.
Region	Japan

Condition
Condition	Kidney transplantation
Classification by specialty	Surgery in general 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, calcineurin inhibitor (CNI), basiliximab and steroids, in compareson with historyical data with MMF, CNI, basiliximab and steroids.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is 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	Calcineurin inhibitor + basiliximab + steroid + 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	16 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.Kidney transplantation. 2.Gender free, any case of uremia. 3. Aged 16 years to 70 years. 4.ABO blood type 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 this study drugs. 2. The patient who has leucopenia. 3. The patient who is pregnant or a female patient who is expecting to become pregnant. 4. The patients who showed a positive result with cross match test. 5. The patient who recived ABO incompatible donor. 6. The patient with whom the physician-in-charge considered inappropriate as a subject of this study.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norio Yoshimura
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Organ Transplantation and General Surgery
Zip code
Address	465 Hirokoji, Kawaramachi, Kamikyo-ku, Kyoto, Japan.
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Study group on a multi-drug combination therapy for renal transplantation
Division name	Department of Organ Transplantation and General Surgery, Kyoto Prefectural University of Medicine
Zip code
Address
TEL	0752515532
Homepage URL
Email

Sponsor
Institute	Study group on a multi-drug combination therapy for renal transplantation
Institute
Department

Funding Source
Organization	The Kidney Foundation, Japan.
Organization
Division
Category of Funding Organization	Non profit foundation
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 31 Day

Related information
URL releasing protocol
Publication of results	Partially published

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 09 Month 04 Day
Date of IRB
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2014 Year 10 Month 31 Day
Date of closure to data entry	2014 Year 10 Month 31 Day
Date trial data considered complete	2014 Year 10 Month 31 Day
Date analysis concluded	2014 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 08 Month 22 Day
Last modified on	2015 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010280

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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