UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001649 |
|---|---|
| Receipt number | 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 23:45:27 |
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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
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
smarubashi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Department of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001986
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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