UMIN-CTR Clinical Trial

Basic information
Public title	A comparative study of renoprotective effect of tolvaptan as an alternative treatment for increasing loop diuretics in patients with chronic kidney disease complicated with chronic heart failure
Acronym	A comparative study of renoprotective effect of tolvaptan as an alternative treatment for increasing loop diuretics in patients with chronic kidney disease complicated with chronic heart failure
Scientific Title	A comparative study of renoprotective effect of tolvaptan as an alternative treatment for increasing loop diuretics in patients with chronic kidney disease complicated with chronic heart failure
Scientific Title:Acronym	A comparative study of renoprotective effect of tolvaptan as an alternative treatment for increasing loop diuretics in patients with chronic kidney disease complicated with chronic heart failure
Region	Japan

Condition
Condition	chronic heart failure, chronic kidney disease
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare long-term renal prognosis treated with additive tolvaptan vs. increased loop diuretics in chronic kidney disease patients with chronic heart failure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum creatinine level eGFR change from baseline Worsening renal function (WRF) from 1 days to 1 years later Days until the dialysis induction Dialysis induction rate
Key secondary outcomes	urine volume, body weight, blood pressure, heart rate, plasma BNP, echocardiography (inferior vena cava diameters, ejection fraction), chest X ray (cardio-thoracic ratio, pulmonary congestion), urine osmolality, Fractional Excretion of Na (FENa), serum BUN, serum Na, serum K , New York heart association cardiac functional classification, cardiovascular event rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tolvaptan group: Add tolvaptan administration
Interventions/Control_2	Furosemide group: Increased furosemide administration
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	Heart failure patients over 20 years of age taking over 40 mg/day furosemide with a estimated GFR (eGFR)<45 mL/min/1.73m2.
Key exclusion criteria	Patients who cannot intake fluids or feel thirst Patients with anuria or urinary excretion disorder Patients with hypernatremia Patients with serious hepatic disorder Patients under the pacing therapy Patients with percutaneous coronary intervention or open heart surgery within the past 3 months Patients with poorly controlled diabetes mellitus Patients who take SGLT-2 inhibitor Patients who are pregnant or possibly pregnant Patients without agreement on enrolment of this study Inappropriate patients judged by doctor
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hisato Middle name Last name Shima
Organization	Kawashima hospital
Division name	Department of Kidney Disease
Zip code	7700011
Address	1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL	088-631-0110
Email	h.shima@khg.or.jp

Public contact
Name of contact person	1st name Hisato Middle name Last name Shima
Organization	Kawashima hospital
Division name	Department of Kidney Disease
Zip code	7700011
Address	1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL	088-631-0110
Homepage URL
Email	h.shima@khg.or.jp

Sponsor
Institute	Kawashima hospital
Institute
Department

Funding Source
Organization	Kawashima hospital
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	Kawashima hospital
Address	1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
Tel	088-631-0110
Email	h.shima@khg.or.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	2019 Year 04 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	Terminated
Date of protocol fixation	2019 Year 03 Month 05 Day
Date of IRB	2019 Year 03 Month 05 Day
Anticipated trial start date	2019 Year 03 Month 07 Day
Last follow-up date	2023 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	2019 Year 03 Month 07 Day
Last modified on	2022 Year 08 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041139