UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016998 |
|---|---|
| Receipt number | R000019611 |
| Scientific Title | Effect of Tolvaptan on polycystic liver and kidney is autosomal dominant polycystic kidney disease |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2015/03/31 19:44:04 |
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Basic information
Public title
Effect of Tolvaptan on polycystic liver and kidney is autosomal dominant polycystic kidney disease
Acronym
GLSG ADPKD
Scientific Title
Effect of Tolvaptan on polycystic liver and kidney is autosomal dominant polycystic kidney disease
Scientific Title:Acronym
GLSG ADPKD
Region
| Japan |
Condition
Condition
ADPKD
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether Tolvaptan can decrease the volume of liver cysts and renal cysts in ADPKD patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of the volume of liver cysts of 12 months (52 weeks) after administration of Tolvaptan to that prior to the treatment
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patients with bilateral renal volume more than or equal to 750 ml. 2. The patients in which the speed of increasing renal volume more than or equal to 5% per year. 3. The patients achieving informed consent to participate in this trial. 4. The patients with liver cysts.
Key exclusion criteria
1. The patient having a history of allergy to Tolvaptan or its analog. 2. The patient cannot feel thirsty or is unable to consume liquid. 3. The patient with hypernatremia. 4. The patient with severe renal function (less than eGFR 15mL/min/1.73m2). 5. The patient with chronic hepatitis or drug-induced liver injury of the history of these disease (except liver cysts). 6. The pregnant woman or the woman who has the possibility of the pregnancy. 7. The patient whom the primary doctor think not appropriate for participating the trial.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sato Ken |
Organization
Gunma University
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL
027-220-8127
satoken@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL
027-220-8127
Homepage URL
satoken@gunma-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
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
Address
Tel
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
| 2020 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint is evaluated by imaging.
Management information
Registered date
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2015 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019611
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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