UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011763
Receipt number R000013754
Scientific Title A Trial of the effect of tolvaptan on patients with nephrotic state and chronic heart failure
Date of disclosure of the study information 2013/11/27
Last modified on 2016/09/15 10:24:02

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Basic information

Public title

A Trial of the effect of tolvaptan on patients with nephrotic state and chronic heart failure

Acronym

a trial of tolvaptan on nephrotic state

Scientific Title

A Trial of the effect of tolvaptan on patients with nephrotic state and chronic heart failure

Scientific Title:Acronym

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

1st name
Middle name
Last name OHTAKE Takayasu

Organization

Shonan Kamakura General Hospital

Division name

Dept. of Nephrology, Immunology and Vascular Medicine

Zip code


Address

Okamoto 1370-1 Kamakura city Kanagawa prefecture

TEL

0467-46-1717

Email

ohtake@shonankamakura.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name OHTAKE Takayasu

Organization

Shonan Kamakura General Hospital

Division name

Dept. of Nephrology, Immunology and Vascular Medicine

Zip code


Address

Okamoto 1370-1 Kamakura city Kanagawa prefecture

TEL

0467-46-1717

Homepage URL


Email

ohtake@shonankamakura.or.jp


Sponsor or person

Institute

Shonan Kamakura General Hospital

Institute

Department

Personal name



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)



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

2013 Year 11 Month 27 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

Completed

Date of protocol fixation

2013 Year 08 Month 20 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013754


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name