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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019256
Receipt No. R000021247
Scientific Title The study of adherence and side effects of immunosuppression therapy after liver transplantation
Date of disclosure of the study information 2015/10/13
Last modified on 2015/10/06

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Basic information
Public title The study of adherence and side effects of immunosuppression therapy after liver transplantation
Acronym Adherence and side effects of immunosupression after liver transplantation
Scientific Title The study of adherence and side effects of immunosuppression therapy after liver transplantation
Scientific Title:Acronym Adherence and side effects of immunosupression after liver transplantation
Region
Japan

Condition
Condition liver transplant patients
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is (i) to evaluate risk factors associated with medicaion non-adherance aaccording to kinds, numbers, and doses of immunosuppressive drugs, (ii) to assess clinical outcomes about side effects and rejection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We assess adherance of immunosuppressive drugs according to questionnaires. The assessment items are as follows; taking dimension, drug holidays, timing dimension, and dose reduction.
Key secondary outcomes the assesment of side effects and rejection at the point of registration and 2 years before registration. Side effects include renal dysfunction, impaired glucose tolerance, and hypertension.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria liver transplant recipients more than one year after operation in outpatient clinic under immunosuppresion therapy
Key exclusion criteria Patients who have not received immunosuppressive drugs

Patients who are not willing to participate in this study
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Yoshizawa
Organization Kyoto University Hospital
Division name Organ Transplant Unit
Zip code
Address 54 Shogoin Kawahara-cho, Kyoto
TEL 075-751-3243
Email ayoshi14@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Yoshizawa
Organization Kyoto University Hospital
Division name Organ Transplant Unit
Zip code
Address 54 Shogoin Kawahara-cho, Kyoto
TEL 075-751-3243
Homepage URL
Email ayoshi14@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 10 Month 13 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
2015 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Registration period is 6 months. Or, registration will be finished when the number of the registration cases reaches 300.

Management information
Registered date
2015 Year 10 Month 06 Day
Last modified on
2015 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021247

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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