UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028060 |
|---|---|
| Receipt number | R000032112 |
| Scientific Title | Inhibition of liver cystogene |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2019/03/15 09:14:45 |
* 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
Inhibition of liver cystogene
Acronym
TVP for PKLD
Scientific Title
Inhibition of liver cystogene
Scientific Title:Acronym
TVP for PKLD
Region
| Japan |
Condition
Condition
Polycystic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we assess the therapeutic value of tolvaptan for PLD in PKD patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in TLV
Key secondary outcomes
Changes in TKV, eGFR, and urinary osmorality
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
Kidney volume>= 750ml
rate of Kidney volume increase >=5%/year
TLV>=2000cm^3
Key exclusion criteria
eGFR<15
Hypernatremia
Chronic liver injury
Patients who do not feel thirsty or have difficulty in ingesting water
Pregnant woman
do not obtain consent
Doctor judged inappropriate
Target sample size
150
Research contact person
Name of lead principal investigator
| 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-to
TEL
03-3588-1111
hoshino-ind@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-to
TEL
03-3588-1111
Homepage URL
hoshino-ind@umin.ac.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Otsuka Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital
Address
2-2-2, Toranomon, Minato-ku
Tel
03-3588-1111
chiken-jim2@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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 07 | Month | 04 | Day |
Last modified on
| 2019 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032112
