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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031781
Receipt No. 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

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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
Email 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
Email kobayashi.hiroki@nihon-u.ac.jp

Sponsor
Institute Nixon University School of Medicine Itabashi Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036282

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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