UMIN-CTR Clinical Trial

Basic information
Public title	Research of Tolvaptan prescription in SIADH patients (Observational research using DPC)
Acronym	Research of Tolvaptan prescription in SIADH patients
Scientific Title	Research of Tolvaptan prescription in SIADH patients (Observational research using DPC)
Scientific Title:Acronym	Research of Tolvaptan prescription in SIADH patients
Region	Japan

Condition
Condition	SIADH
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will investigate Tolvaptan prescription in actual clinical practice in SIADH patients (starting dose, etc.) after the indication of "improvement of hyponatremia secondary to SIADH" was added in June 2020.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	-Tolvaptan prescription in actual clinical practice (starting dose, increase / decrease, prescription period, re-administration) - Changes in serum sodium concentration, occurrence of rapid correction of hyponatremia (by Tolvaptan dose)
Key secondary outcomes	-Patient demographic and clinical characteristics

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-Patients with a diagnosis of "ICD10E222: Syndrome of inappropriate secretion of antidiuretic hormone <SIADH>" during the enrollment period
Key exclusion criteria	- Patients under 18 years old
Target sample size	2800

Research contact person
Name of lead principal investigator	1st name Miyuki Middle name Last name Matsukawa
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Medical Affairs Department
Zip code	540-0021
Address	3-2-27, Otedori, Chuo-ku, Osaka-shi, Osaka 540-0021, Japan
TEL	080-6791-7646
Email	Matsukawa.miyuki@otsuka.jp

Public contact
Name of contact person	1st name Miyuki Middle name Last name Matsukawa
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Medical Affairs Department
Zip code	540-0021
Address	3-2-27, Otedori, Chuo-ku, Osaka-shi, Osaka 540-0021, Japan
TEL	080-6791-7646
Homepage URL
Email	Matsukawa.miyuki@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd. Medical Affairs Department
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd. Medical Affairs Department
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	RIHDS Ethics Review Board
Address	2-5-5 Shibadaimon, Minato-ku, Tokyo Sumitomo Shibadaimon Building 12th floor, inside JMDC Co., Ltd.
Tel	03-5733-5010
Email	rihds@jmdc.co.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	2022 Year 03 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	2800
Results	As a result of examination using actual clinical data using the DPC database, half of the tolvaptan starting dose to SIADH was started from a low dose (3.75 mg), and the average administration period was 32.7 days for 3.75 mg and 33.1 days for 7.5 mg. Since mean of the serum sodium concentration at the start of the tolvaptan-administered case was 120.30 mEq / L, it is considered that the appropriate starting dose was selected for administration.
Results date posted	2022 Year 07 Month 14 Day
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	Completed
Date of protocol fixation	2021 Year 12 Month 08 Day
Date of IRB	2021 Year 12 Month 03 Day
Anticipated trial start date	2022 Year 03 Month 02 Day
Last follow-up date	2022 Year 05 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 07 Month 12 Day

Other
Other related information	Research of Tolvaptan prescription

Management information
Registered date	2022 Year 02 Month 24 Day
Last modified on	2022 Year 07 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053594