UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040545 |
|---|---|
| Receipt number | R000046282 |
| Scientific Title | Risk assessment of hepatitis B virus reactivation in renal transplant patient |
| Date of disclosure of the study information | 2020/05/27 |
| Last modified on | 2022/03/10 15:01:44 |
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Basic information
Public title
Risk assessment of hepatitis B virus reactivation in renal transplant patient
Acronym
HBV reactivation in renal transplant patient
Scientific Title
Risk assessment of hepatitis B virus reactivation in renal transplant patient
Scientific Title:Acronym
HBV reactivation in renal transplant patient
Region
| Japan |
Condition
Condition
hepatitis B virus
renal transplant patient
Classification by specialty
| Hepato-biliary-pancreatic medicine | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess HBV reactivation in renal transplant patients
Basic objectives2
Others
Basic objectives -Others
To analyze the occurrence rate of HBV reactivation in each status of HBV infection
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To analyze the occurrence rate of HBV reactivation in renal transplant patients
Key secondary outcomes
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.Patients who are 20 years of age or older at the time of obtaining informed consent
2..Patients who are informed and have provided written informed consent to participate in the study prior to study initiation
3. Renal donor who do not meet any of the following exclusion criteria
4.Renal recipient who do not meet any of the following exclusion criteria
Key exclusion criteria
1.Patients with difficult controlled cardiac disease
2.Patients by whom doctor in charge has determined to be inappropriate as a subject
3.Patients by whom principal investigator has determined to be inappropriate as a subject
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kiyohiko |
| Middle name | |
| Last name | Hotta |
Organization
Hokkaido University Hospital
Division name
Department of Renal and Genitourinary surgery
Zip code
060-8648
Address
KIta 15, NIshi 7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL
011-706-5772
hotta1125@mac.com
Public contact
Name of contact person
| 1st name | Kiyohiko |
| Middle name | |
| Last name | Hotta |
Organization
Hokkaido University Hospital
Division name
Department of Renal and Genitourinary surgery
Zip code
060-8648
Address
KIta 15, NIshi 7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL
011-706-5772
Homepage URL
https://toms.med.hokudai.ac.jp/
hotta1125@mac.com
Sponsor or person
Institute
Department of Renal and Genitourinary surgery
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Renal and Genitourinary surgery
Hokkaido University Hospital
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
KIta 15, NIshi 7, Kita-ku, Sapporo-shi, Hokkaido, Japan
Tel
011-716-1161
crjimu@huhp.hokudai.ac.jp
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2035 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2035 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2036 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observation study
Management information
Registered date
| 2020 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046282
