UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049348 |
|---|---|
| Receipt number | R000056150 |
| Scientific Title | Efficacy and Safety of Sacubitril/Valsartan in Hemodialysis Patients with Hypertension |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/04/28 18:17:35 |
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Basic information
Public title
Efficacy and Safety of Sacubitril/Valsartan in Hemodialysis Patients with Hypertension
Acronym
Efficacy and Safety of Sacubitril/Valsartan in Hemodialysis Patients with Hypertension
Scientific Title
Efficacy and Safety of Sacubitril/Valsartan in Hemodialysis Patients with Hypertension
Scientific Title:Acronym
Efficacy and Safety of Sacubitril/Valsartan in Hemodialysis Patients with Hypertension
Region
| Japan |
Condition
Condition
End-stage renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the efficacy and safety of sacubitril/valsartan in comparison with an angiotensin II receptor blocker in Japanese hemodialysis patients with hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of blood pressure during hemodialysis after 3 months.
Key secondary outcomes
1. Change in home blood pressure
2. Change in liver function and electrolytes
3. Change in NT-proBNP
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
All patients were switched from angiotensin receptor II blocker to sacubitril/valsartan. Patients were initially instructed to take sacubitril/valsartan 50 mg once daily, and the dosage was gradually increased up to 200 mg once daily and continued 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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 18 years and over
2. Receiving thrice-weekly maintenance hemodialysis with session length more than or equal to 3 hours.
3. Receiving maintenance hemodialysis for more than 90 days.
Key exclusion criteria
1. Non-sinus rhythm
2. Life expectancy of less than one year
3. Apparent infection
4. Myocardial infarction and/or stroke within 30 days
5. Current pregnancy
6. Malignancy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Ishimitsu |
Organization
Utsunomiya Central Hospital
Division name
Department of Internal Medicine
Zip code
321-0953
Address
2-1-1, Higashi-shukugou, Utsunomiya city, Tochigi
TEL
0286351110
t-ishimitsu@sun.ucatv.ne.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Iwashima |
Organization
Kansai Medical University Kori Hospital
Division name
Department of Internal Medicine
Zip code
572-8551
Address
8-45 Kori Hon-douri chou, Neyagawa city, Osaka
TEL
0728325321
Homepage URL
iwashimy@kouri.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None.
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
Gitennyama Hospital
Address
1682-2, Shin-imamiya-chou, Kanuma city, Tochigi
Tel
0289-64-2131
touseki@gotenyama.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
| 2022 | Year | 11 | 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
27
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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056150
| 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 |
