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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036119
Receipt No. R000041139
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
Date of disclosure of the study information 2019/04/01
Last modified on 2019/03/07

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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
Middle name
Last name Hisato Shima
Organization Kawashima hospital
Division name Department of Kidney Disease
Zip code
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
Middle name
Last name Hisato Shima
Organization Kawashima hospital
Division name Department of Kidney Disease
Zip code
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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 07 Day
Last follow-up date
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
2019 Year 03 Month 07 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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