UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028060
Receipt No. R000032112
Scientific Title Inhibition of liver cystogene
Date of disclosure of the study information 2017/10/01
Last modified on 2019/03/15

* 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
Email 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
Email hoshino-ind@umin.ac.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032112

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.