Unique ID issued by UMIN | UMIN000014763 |
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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 |
The Randomized Controlled Trial for Evaluating the Efficacies of Tolvaptan in Patients with Chronic Kidney Disease
The Efficacies of Tolvaptan in Patients with CKD
The Randomized Controlled Trial for Evaluating the Efficacies of Tolvaptan in Patients with Chronic Kidney Disease
The Efficacies of Tolvaptan in Patients with CKD
Japan |
chronic kidney disease
Nephrology |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
change of urine output
1) serum Cr
2) serum Na
3) body weight
4) symptoms of volume overload
5)the indispensability days untill a discharge
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Central registration
2
Treatment
Medicine |
Add oral tolvaptan 15mg/day to the conventional therapy for a week
Add oral furosemide 100mg/day to the conventional therapy for a week
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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
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
50
1st name | Akira |
Middle name | |
Last name | Fujiwara |
Yokohama City University Medical Center
Department of Nephrology and Hypertension
232-0024
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
sh.2.komiya@gmail.com
1st name | Shiro |
Middle name | |
Last name | Komiya |
Yokohama City University Medical Center
Department of Nephrology and Hypertension
232-0024
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
sh.2.komiya@gmail.com
Yokohama City University Medical Center
Yokohama City University Hospital
None
Self funding
Japan
Yokohama City University Ethics Committee
3-9 Fukuura,Kanazawa-ku,Yokohama 236-0004 Japan
045-370-7629
nextjim1@yokohama-cu.ac.jp
NO
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)
2014 | Year | 08 | Month | 05 | Day |
Unpublished
50
No longer recruiting
2014 | Year | 07 | Month | 30 | Day |
2014 | Year | 07 | Month | 31 | Day |
2014 | Year | 08 | Month | 06 | Day |
2021 | Year | 03 | Month | 31 | Day |
2014 | Year | 08 | Month | 05 | Day |
2022 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017165
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