UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001649
Receipt No. R000001986
Scientific Title The evaluation of efficacy and safety in modification to new immunosuppressant (tacrolimus hydrate:Graceptor) from the current immunosuppressive therapy after liver transplantation
Date of disclosure of the study information 2014/01/31
Last modified on 2010/02/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The evaluation of efficacy and safety in modification to new immunosuppressant (tacrolimus hydrate:Graceptor) from the current immunosuppressive therapy after liver transplantation
Acronym The evaluation of efficacy and safety in modification to new immunosuppressant (tacrolimus hydrate:Graceptor) from the current immunosuppressive therapy after liver transplantation
Scientific Title The evaluation of efficacy and safety in modification to new immunosuppressant (tacrolimus hydrate:Graceptor) from the current immunosuppressive therapy after liver transplantation
Scientific Title:Acronym The evaluation of efficacy and safety in modification to new immunosuppressant (tacrolimus hydrate:Graceptor) from the current immunosuppressive therapy after liver transplantation
Region
Japan

Condition
Condition Adult Recipients after liver transplantation
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy and safety in modification to new immunosuppressant (tacrolimus hydrate:Graceptor) from the current immunosuppressive therapy after liver transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Area under the blood
concentration time curve
Clinical Response
Key secondary outcomes Clinical Response
Incidence of Adverse Event
A change of tacrolimus blood
trough level
A change of tacrolimus blood
peak level
Drug compliance

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Adults recipients after liver transplantation
2 The recipients who agree to
this study
3 more than 6 months after liver
transplantation
4 clinicopathologically diagnosed
with well functioning
Key exclusion criteria 1 clinicopathologically diagnosed
with rejection in recent 90
days .
2 underwent rejection treatment
in recent 6 months

3 diagnosed with rejection beyond
twice in 12 months

4 liver dysfunction ,AST>=40, or
ALT>=40

5 Drug user of cross interaction
with Tacrolimus

6 Other severe concomitant
disease or medical conditions.
7 drug abuser, mentally unstable
recipient, The patient who was
judged to have difficulty in
communication with the doctor

8 History of contraindication to
tacrolimus.

9 A pregnant woman or a woman
with possibility becoming
pregnant
10 severe renal dysfunction

11 Inappropriate patients for
entry on this trial in the
judgement of the investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Mori, MD., PhD
Organization Graduate School of Medicine, Osaka University
Division name Department of Surgery
Zip code
Address 2-2, Yamadaoka E-2, Suita 565-0871 Osaka, Japan
TEL 06-6879-3251
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Marubashi, MD., PhD
Organization Graduate School of Medicine, Osaka University
Division name Department of Surgery
Zip code
Address 2-2, Yamadaoka E-2, Suita 565-0871 Osaka, Japan
TEL 06-6879-3251
Homepage URL
Email smarubashi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Osaka University
Department of Surgery
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 01 Month 31 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 Preinitiation
Date of protocol fixation
2008 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2014 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2009 Year 01 Month 21 Day
Last modified on
2010 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001986

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.