UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019256 |
|---|---|
| Receipt number | 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 20:55:29 |
* 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 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
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
ayoshi14@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
