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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021708
Receipt No. 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 2018/04/04

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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 Administration of Tolvaptan once per day (60mg/day, 90mg/day, 120mg/day), each dose for two days.
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
Middle name
Last name Noriko Makita
Organization The University of Tokyo Hospital
Division name Nephrology and Endocrinology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email norimaki-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsunori Manaka
Organization The University of Tokyo Hospital
Division name Nephrology and Endocrinology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email manaka-tky@umin.ac.jp

Sponsor
Institute Department of Nephrology and Endocrinology, The University of Tokyo Hospital
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2016 Year 04 Month 18 Day
Last follow-up date
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
2018 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024903

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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