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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014763
Receipt No. R000017165
Scientific Title The Randomized Controlled Trial for Evaluating the Efficacies of Tolvaptan in Patients with Chronic Kidney Disease
Date of disclosure of the study information 2014/08/05
Last modified on 2019/01/29

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Basic information
Public title The Randomized Controlled Trial for Evaluating the Efficacies of Tolvaptan in Patients with Chronic Kidney Disease
Acronym The Efficacies of Tolvaptan in Patients with CKD
Scientific Title The Randomized Controlled Trial for Evaluating the Efficacies of Tolvaptan in Patients with Chronic Kidney Disease
Scientific Title:Acronym The Efficacies of Tolvaptan in Patients with CKD
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacies of tolvaptan in patients with congestive heart failure and chronic kidney disease stage 3-5, by comparing with the treatment which increases the dose of furosemide.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes change of urine output
Key secondary outcomes 1) serum Cr
2) serum Na
3) body weight
4) symptoms of volume overload
5)the indispensability days untill a discharge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Add oral tolvaptan 15mg/day to the conventional therapy for a week
Interventions/Control_2 Add oral furosemide 100mg/day to the conventional therapy for a week
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients have ability to provide written informed consent
2)Patients between 20-85 years of age at the time of enrolling
3)Patients with chronic kidney disease stage 3-5 (eGFR < 60mL/min/1.73m2 )
4)Patients with heart failure have at least one or more the following body fluid retention symptoms ; pleural effusion / ascites / lower limb edema / blepharedema / pulmonary congestion / juglar venous distention
5)Patients given oral furosemide 20-100mg/day at the time of enrolling
Key exclusion criteria 1)Patients undergoing hemodialysis or peritoneal dialysis during the study period
2)Previous history of tolvaptan use
3)The anuric patients
4)Patients without a sense of thirst
5)Patients without ability to intake water
6)Serum Na >=146mEq/L (within 3 days from a registration day)
7)Patients showing allergy to tolvaptan
8)Other cases which treating physicians regards as inappropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mari Katsumata
Organization Yokohama City University Medical Center
Division name Department of Nephrology and Hypertension
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email kougaisui@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mari Katsumata
Organization Yokohama City University Medical Center
Division name Department of Nephrology and Hypertension
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email kougaisui@yahoo.co.jp

Sponsor
Institute Yokohama City University Medical Center
Yokohama City University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 05 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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 06 Day
Last follow-up date
2019 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 05 Day
Last modified on
2019 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017165

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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