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
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
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
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
