UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031781 |
|---|---|
| Receipt number | R000036282 |
| Scientific Title | The efficacy of tolvaptan for patients with chronic kidney disease and chronic heart failure |
| Date of disclosure of the study information | 2018/03/18 |
| Last modified on | 2019/03/20 05:13:21 |
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Basic information
Public title
The efficacy of tolvaptan for patients with chronic kidney disease and chronic heart failure
Acronym
The efficacy of tolvaptan in patients with chronic kidney disease
Scientific Title
The efficacy of tolvaptan for patients with chronic kidney disease and chronic heart failure
Scientific Title:Acronym
The efficacy of tolvaptan in patients with chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the efficacy of tolvaptan for CKD patients with volume overload.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urine volume, body weight, blood pressure
Physical assessment
L/D (Na, K, Cl, osmolarity, BUN,Cr, ADH, urine electrolytes, L-FABP, NAG)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CKD patients (stage3, stage4, stage5) who were prescribed tolvaptan
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Abe |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension, and Endocrinology
Zip code
173-8610
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
abe.masanori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kobayashi |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension, and Endocrinology
Zip code
173-8610
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
Homepage URL
kobayashi.hiroki@nihon-u.ac.jp
Sponsor or person
Institute
Nixon University School of Medicine Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Nihon University School of Medicine Itabashi Hospital
Address
30-1, Oyaguchi kamichou, Itabashiku, Tokyo
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.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
| 2018 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under investigated
Management information
Registered date
| 2018 | Year | 03 | Month | 18 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036282
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
