UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010743
Receipt number R000012084
Scientific Title Analysis of immunological status using CFSE-MLR for de-novo kidney transplant recipients who are treated with Everolimus commencing 3 months after surgery.
Date of disclosure of the study information 2013/05/16
Last modified on 2020/03/11 21:02:49

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Basic information

Public title

Analysis of immunological status using CFSE-MLR for de-novo kidney transplant recipients who are treated with Everolimus commencing 3 months after surgery.

Acronym

Analysis of immunological status using CFSE-MLR for kidney transplant recipients treated with Everolimus.

Scientific Title

Analysis of immunological status using CFSE-MLR for de-novo kidney transplant recipients who are treated with Everolimus commencing 3 months after surgery.

Scientific Title:Acronym

Analysis of immunological status using CFSE-MLR for kidney transplant recipients treated with Everolimus.

Region

Japan


Condition

Condition

After kidney transplantation

Classification by specialty

Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Exploratory study of analysis of immunological status using CFSE-MLR for kidney transplant recipients treated with reduced Cyclosporine plus Everolimus.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of CFSE-MLR categorization between reduced Cyclosporine plus Everolimus group and normal dose Cyclosporine group.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Reduced Cyclosporine plus Everolimus treatment

Interventions/Control_2

Normal dose Cyclosporine

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

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

de-novo kidney transplant recipients

Key exclusion criteria

rejection
severe proteinuria

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Ohdan

Organization

Hiroshima University Hospital

Division name

Trasnplantation surgery

Zip code

734-8551

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

0822575222

Email

hohdan@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Ide

Organization

Hiroshima University Hospital

Division name

Trasnplantation surgery

Zip code

734-8551

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

082-257-5222

Homepage URL


Email

ideken@hiroshima-u.ac.jp


Sponsor or person

Institute

Trasnplantation surgery, Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Trasnplantation surgery, Hiroshima University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Center for Integrated Medical Research

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

Tel

082-257-1752

Email

protocol@cimr.hiroshima-u.ac.jp


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

2013 Year 05 Month 16 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

80

Results

No significant difference was found between reduced Cyclosporine plus Everolimus group and normal dose Cyclosporine group in CFSE-MLR categorization.

Results date posted

2020 Year 03 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

After kidney transplantation

Participant flow

Parallel
Randomized
Open -no one is blinded

Adverse events

Hyperlipidemia etc.

Outcome measures

Comparison of CFSE-MLR categorization between reduced Cyclosporine plus Everolimus group and normal dose Cyclosporine group.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 03 Month 26 Day

Date of IRB

2013 Year 05 Month 15 Day

Anticipated trial start date

2013 Year 05 Month 15 Day

Last follow-up date

2017 Year 06 Month 30 Day

Date of closure to data entry

2017 Year 06 Month 30 Day

Date trial data considered complete

2017 Year 06 Month 30 Day

Date analysis concluded

2017 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 05 Month 16 Day

Last modified on

2020 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name