UMIN-CTR Clinical Trial

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
Email	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
Email	tkogure@med.tohoku.ac.jp

Sponsor
Institute	Tohoku Medical and Pharmaceutical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051036