UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015793
Receipt number R000018202
Scientific Title Chronotherapy of methylprednisolone in pediatric liver transplanted recipients
Date of disclosure of the study information 2014/11/30
Last modified on 2014/11/30 10:17:45

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Basic information

Public title

Chronotherapy of methylprednisolone in pediatric liver transplanted recipients

Acronym

Chronotherapy of methylprednisolone

Scientific Title

Chronotherapy of methylprednisolone in pediatric liver transplanted recipients

Scientific Title:Acronym

Chronotherapy of methylprednisolone

Region

Japan


Condition

Condition

After liver transplantation

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clarify whether night-time dosing of methylprednisolone would suppressed the ratio of acute rejection in pediatric liver transplanted recipients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Ratio of acute rejection

Key secondary outcomes

Ratio of any adverce effects


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Dosing of methylprednisolone at morning

Interventions/Control_2

Dosing of methylprednisolone at evening

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

0 years-old <=

Age-upper limit

15 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patients who received living-related liver transplantation
2. Patients who are less than 15 years old

Key exclusion criteria

1. Patients who need an urgently transplantation because fulminant hepatitis
2. Judged inappropriate to participate in this study by a doctor

Target sample size

170


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Mizuta

Organization

Jichi Medical University

Division name

Division of Transplant Surgery

Zip code


Address

3311-1 Yakushiji, Shimotsuke, Tochigi, Japan

TEL

0285-58-7069

Email

koimizu@jichi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Ushijima

Organization

Jichi Medical University

Division name

Division of Clinical Pharmacology

Zip code


Address

3311-1 Yakushiji, Shimotsuke, Tochigi, Japan

TEL

0285-58-7388

Homepage URL


Email

ushijima-kentarou@umin.ac.jp


Sponsor or person

Institute

Division of Transplant Surgery, Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Jichi Medical University

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



Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 30 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

Enrolling by invitation

Date of protocol fixation

2014 Year 11 Month 11 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 11 Month 30 Day

Last modified on

2014 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018202


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name