UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008751
Receipt number R000010280
Scientific Title Multicenter study of combination therapy using calcineurin inhibitor, basiliximab, mizoribine and steroids in kidney transplantation.
Date of disclosure of the study information 2012/08/31
Last modified on 2015/01/06 14:32:10

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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