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 | 2025/03/31 13:53:22 |
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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
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
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
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
None
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10157-022-02224-x
Number of participants that the trial has enrolled
50
Results
In patients with advanced CKD with fluid overload, the addition of TLV achieved a significantly higher urine
volume with less adverse effects on renal function compared with increasing the dose of FUR.
Clinical Experimental Nephrology
Results date posted
| 2025 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
The patients were predominantly male and ranged in age from 44 to 84 years. eGFR was 13.7 and 13.8.
Participant flow
In all, 35 patients were randomized. One patient met the exclusion criteria and did not receive study treatment. 1 patient was found not to meet the diagnostic criteria for heart failure and was excluded. A total of 33 patients were thus treated and used for analysis.
Adverse events
One patient with dry mouth and one with hypernatremia were observed in the TLV group, and one patient with hypotension and two with hyponatremia were observed in the FUR group. No serious adverse events were observed.
Outcome measures
The mean change in urine volume was significantly higher in the TLV group compared to the FUR group (637 ml vs 119 ml; p < 0.05). The difference was greater when the urine osmolality before treatment was high. Serum creatinine was increased only in the FUR group. The incidence of worsening renal function (WRF) was significantly lower in the TLV group (18.8% vs 58.8%; p < 0.05). Serum sodium decreased significantly in the FUR group, but did not change in the TLV group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017165
