UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Trial of the effect of tolvaptan on patients with nephrotic state and chronic heart failure
Title of the study (Brief title)	a trial of tolvaptan on nephrotic state
Region	Japan

Condition
Condition	nephrotic syndrome with heart failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we will study for the efficiency and safety of tolvaptan on patients with heart falure who have edema and nephrotic syndrome
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	edema
Key secondary outcomes	change in urine volume (every day) change in body weight (day 8)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	tolvaptan
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	objects must meet every criteria 1. who have heart failure with diuresis 2. who have edema and nephrotic syndrome *the definition of nephrotic syndrome (1) urinary protein >3.5g/day continues (2) serum protein <= 6.0g/dl (or serum albumin <= 3.0g/dl) 3. inpatient
Key exclusion criteria	1. who have the history of the allergy to this drug or related compounds 2. anuria (<100ml/day) 3. who do not feel thirst or who have difficulty in drinking 4. serum Na >145mEq/l 5. women who are pregnant or have the possibility of pregnancy
Target sample size	20

Research contact person
Name of lead principal investigator	OHTAKE Takayasu
Organization	Shonan Kamakura General Hospital
Division name	Dept. of Nephrology, Immunology and Vascular Medicine
Address	Okamoto 1370-1 Kamakura city Kanagawa prefecture
TEL	0467-46-1717
Email	ohtake@shonankamakura.or.jp

Public contact
Name of contact person	OHTAKE Takayasu
Organization	Shonan Kamakura General Hospital
Division name	Dept. of Nephrology, Immunology and Vascular Medicine
Address	Okamoto 1370-1 Kamakura city Kanagawa prefecture
TEL	0467-46-1717
Homepage URL
Email	ohtake@shonankamakura.or.jp

Sponsor
Institute	Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization	Shonan Kamakura General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 11 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 20 Day
Anticipated trial start date	2013 Year 09 Month 14 Day
Last follow-up date	2014 Year 10 Month 30 Day
Date of closure to data entry	2014 Year 10 Month 30 Day
Date trial data considered complete	2014 Year 10 Month 30 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 13 Day
Last modified on	2016 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013754