UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044693 |
|---|---|
| Receipt number | R000051036 |
| Scientific Title | Study of the renal protective effect of tolvaptan as a replacement of loop diuretics for the treatment of ascites in cirrhotic patients with renal dysfunction |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/07/20 12:12:16 |
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Basic information
Public title
Study of the renal protective effect of tolvaptan as a replacement of loop diuretics for the treatment of ascites in cirrhotic patients with renal dysfunction
Acronym
Renal protective effect of tolvaptan for cirrhotic patients
Scientific Title
Study of the renal protective effect of tolvaptan as a replacement of loop diuretics for the treatment of ascites in cirrhotic patients with renal dysfunction
Scientific Title:Acronym
Renal protective effect of tolvaptan for cirrhotic patients
Region
| Japan |
Condition
Condition
liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of switching from loop diuretics to tolvaptan in liver cirrhosis with renal dysfunction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in eGFR and serum creatinine levels after 12 weeks of administration of tolvaptan
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of tolvaptan, 3.75 mg-7.5 mg for 12 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with hepatic ascites associated with uncompensated liver cirrhosis who have been taking furosemide for at least 6 months
2. Patients with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min
Key exclusion criteria
1. Patients with active infections, including spontaneous bacterial peritonitis
2. Patients with carcinomatous peritonitis
3. Patients with chronic kidney disease or heart failure
4. Patients with hepatocellular carcinoma or esophagogastric varices within 6 months of treatment
5. Patients receiving vasopressin antagonist
6. Women who are pregnant, potentially pregnant, within 28 days after delivery, or breast-feeding
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kogure |
Organization
Tohoku Medical and Pharmaceutical University Hospital
Division name
Gastroenterology
Zip code
983-8512
Address
1-12-1 Fukumuro, Miyagino-ku, Sendai, Japan
TEL
022-259-1221
tkogure@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kogure |
Organization
Tohoku Medical and Pharmaceutical University Hospital
Division name
Gastroenterology
Zip code
983-8512
Address
1-12-1 Fukumuro, Miyagino-ku, Sendai, Japan
TEL
022-259-1221
Homepage URL
tkogure@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku Medical and Pharmaceutical University Hospital
Address
1-12-1 Fukumuro, Miyagino-ku, Sendai, Japan
Tel
022-259-1221
tiken@hosp.tohoku-mpu.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
| 2021 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 06 | 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
| 2021 | Year | 06 | Month | 29 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051036
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
