UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021708 |
|---|---|
| Receipt number | R000024903 |
| Scientific Title | A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene. |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2021/10/07 19:38:01 |
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Basic information
Public title
A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene.
Acronym
A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene.
Scientific Title
A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene.
Scientific Title:Acronym
A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene.
Region
| Japan |
Condition
Condition
Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety of Tolvaptan in patients with Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urine Volume
Key secondary outcomes
Urine Osmolarity, amount of water drinking, Urine AQP2, safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) Administration of Tolvaptan once per day (60mg/day, 90mg/day, 120mg/day), each dose for two days.
2) Administration of Tolvaptan 120mg per day for 2 to 4 weeks in outpatient.
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
1) Over 20 years old
2) Patients who have been diagnosed with nephrogenic diabetes insipidus caused by mutations in the vasorepssin type 2 receptor gene.
3) Doctor's decision based on the tests at routine outpatient visits
4) Written informed consent after a detailed explanation of this study
Key exclusion criteria
1) History of allergy to tolvaptan
2) Pregnant women and women suspected of being pregnant
3) Severe Renaldysfunction (eGFR < 30 mL/min/1.73m2)
4) Severe liver dysfunction (AST > 100 U/L or ALT > 100 U/L)
5) Congestive heart failure
6) Active TBc
7) Substance use disorder
8) Use of investigational drug within 4 months before participation of this study
9) Amount of whole blood sampling > 200 mL within 4 weeks, amount of whole blood sampling > 400 mL within 12 weeks, or plasmapheresis / platelet apheresis within 2 weeks.
10) Doctor's decision
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Makita |
Organization
The University of Tokyo Hospital
Division name
Nephrology and Endocrinology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
norimaki-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Katsunori |
| Middle name | |
| Last name | Manaka |
Organization
The University of Tokyo Hospital
Division name
Nephrology and Endocrinology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
manaka-tky@umin.ac.jp
Sponsor or person
Institute
Department of Nephrology and Endocrinology, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Healthcare coopration
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
The University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.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
| 2016 | Year | 04 | Month | 18 | 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
| 2016 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024903
