UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012865 |
|---|---|
| Receipt number | R000015035 |
| Scientific Title | Ursodeoxycholic acid for polycystic liver disease |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2022/07/23 09:20:15 |
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Basic information
Public title
Ursodeoxycholic acid for polycystic liver disease
Acronym
UDCA for PLD
Scientific Title
Ursodeoxycholic acid for polycystic liver disease
Scientific Title:Acronym
UDCA for PLD
Region
| Japan |
Condition
Condition
polycystic liver disease, polycystic kidney disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Assess the effect of Ursodeoxycholic acid (UDCA) in patients with hepatobiliary enzyme abnormalities caused by enlarged polycystic liver.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
normalization of biliary enzymes, and decrease the rate of cyst progression.
Key secondary outcomes
improvement of nutrition markers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
UDCA 600mg/day
Interventions/Control_2
standard treatment
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
presence of abnormality of biliary enzyme caused by polycystic liver.
Key exclusion criteria
Patients with jaundice (T-Bil>2.0mg/dL), complete obstruction of biliary ducts, or fulminant hepatitis.
Patients with severe pancrease disease, GB stone, or gastric ulcers.
Patients who received hepatic TAE within a year.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenmei |
| Middle name | |
| Last name | Takaichi |
Organization
Toranomon Hospital
Division name
Nephrology center
Zip code
1058470
Address
2-2-2, Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
takaichi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Hoshino |
Organization
Toranomon Hospital
Division name
Nephrology Center
Zip code
1058470
Address
2-2-2, Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
Homepage URL
hoshino@toranomon.gr.jp
Sponsor or person
Institute
Nephrology Center, Toranomon Hospital
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
Institutional Review Board, Toranomon Hospital
Address
2-2-2, Toranomon, Minato-ku
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
虎の門病院（東京都）、虎の門病院分院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.kkr.or.jp/hospital/toranomon/
Publication of results
Partially published
Result
URL related to results and publications
Nihon Jinzo Gakkai Shi, 61(6) Page777(2019.08)
Number of participants that the trial has enrolled
13
Results
No significant change of total liver volume was observed between two groups.
Results date posted
| 2021 | Year | 01 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
PKD patients with huge PLD.
Participant flow
Recruited by invitation
Adverse events
None
Outcome measures
Change of total liver volume
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 15 | Day |
Last modified on
| 2022 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015035
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
