UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014763
Receipt number 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 2022/03/16 13:32:05

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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 Akira
Middle name
Last name Fujiwara

Organization

Yokohama City University Medical Center

Division name

Department of Nephrology and Hypertension

Zip code

232-0024

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

sh.2.komiya@gmail.com


Public contact

Name of contact person

1st name Shiro
Middle name
Last name Komiya

Organization

Yokohama City University Medical Center

Division name

Department of Nephrology and Hypertension

Zip code

232-0024

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL


Email

sh.2.komiya@gmail.com


Sponsor or person

Institute

Yokohama City University Medical Center
Yokohama City University Hospital

Institute

Department

Personal name



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

Yokohama City University Ethics Committee

Address

3-9 Fukuura,Kanazawa-ku,Yokohama 236-0004 Japan

Tel

045-370-7629

Email

nextjim1@yokohama-cu.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

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

50

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

2014 Year 07 Month 30 Day

Date of IRB

2014 Year 07 Month 31 Day

Anticipated trial start date

2014 Year 08 Month 06 Day

Last follow-up date

2021 Year 03 Month 31 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

2022 Year 03 Month 16 Day



Link to view the page

Value
https://center6.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