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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name