UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009120
Receipt number 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 16:51:51

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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

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

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 or person

Institute

AMCT

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


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

Value
https://center6.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