UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036119 |
|---|---|
| Receipt number | 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 | 2022/08/02 23:11:47 |
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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 | 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
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
h.shima@khg.or.jp
Sponsor or person
Institute
Kawashima hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041139
