UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034785 |
|---|---|
| Receipt number | R000039664 |
| Scientific Title | Comparative study of the effect of continuous administration of ETV (entecavir) or switching to TAF (tenofovir araphenamide fumarate) on renal function in cases with HBV infection during ETV administration |
| Date of disclosure of the study information | 2018/11/06 |
| Last modified on | 2023/05/11 09:32:43 |
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Basic information
Public title
Comparative study of the effect of continuous administration of ETV (entecavir) or switching to TAF (tenofovir araphenamide fumarate) on renal function in cases with HBV infection during ETV administration
Acronym
Renal function of ETV continuation or switching to TAF in ETV administrating hepatitis B patients
Scientific Title
Comparative study of the effect of continuous administration of ETV (entecavir) or switching to TAF (tenofovir araphenamide fumarate) on renal function in cases with HBV infection during ETV administration
Scientific Title:Acronym
Renal function of ETV continuation or switching to TAF in ETV administrating hepatitis B patients
Region
| Japan |
Condition
Condition
Chronic hepatits B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the safety and efficacy of the therapy of ETV (entecavir) continuation or switching to TAF (tenofovir alafenamide fumarate) in ETV administrating cases with chronic HBV infection with impaired renal function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in estimated glomerular filtration rate (eGFR) between the 2 groups from 48 weeks, 96 weeks, and 144 weeks after randomization.
Key secondary outcomes
Difference in changes HBV markers between the 2 groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous administration of ETV
0.5 mg a day p.o. continuously
(Cases with prolonged dosing intervals due to renal impairment will continue as is.)
Interventions/Control_2
Switching to TAF
25 mg a day p.o. continuously
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
HBV-infected patients who received ETV for more than 1 year and satisfy all of the following criteria.
1)eGFR is continuously 60 ml/min/1.73m2 or less.
2) ETV oral compliance is maintained.
3) The antiviral effect is well maintained. (HBV DNA <1.3 log IU/ml)
Key exclusion criteria
1) Patients with CCr (Cockcroft-Gault) less than 15 mL/min.
2) Patients who are concurrently administering with other nucleoside or nucleotide analogue.
3) Patients who the doctor in charge considers inappropriate as the subject in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Hige |
Organization
Sapporo-Kosei General Hospital
Division name
Department of Hepatology
Zip code
060-0033
Address
5 Kita 3 , Higashi 8, Chuo-ku, Sapporo
TEL
011-261-5331
shuhei.hige@ja-hokkaidoukouseiren.or.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Hige |
Organization
Sapporo-Kosei General Hospital
Division name
Department of Hepatology
Zip code
060-0033
Address
5 Kita 3 , Higashi 8, Chuo-ku, Sapporo
TEL
011-261-5331
Homepage URL
shuhei.hige@ja-hokkaidoukouseiren.or.jp
Sponsor or person
Institute
Sapporo-Kosei General Hospital
Department of Hepatology
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Sapporo-Kosei General Hospital
Address
5 Kita 3 , Higashi 8, Chuo-ku, Sapporo
Tel
011-261-5331
shuhei.hige@ja-hokkaidoukouseiren.or.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
札幌厚生病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 06 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039664
