UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048227 |
|---|---|
| Receipt number | R000054961 |
| Scientific Title | Verification of the effect of sacubitril valsartan sodium hydrate on the residual renal function of peritoneal dialysis patients |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2024/01/01 09:24:49 |
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Basic information
Public title
Verification of the effect of sacubitril valsartan sodium hydrate on the residual renal function of peritoneal dialysis patients
Acronym
Verification of the effect of sacubitril valsartan sodium hydrate on the residual renal function of peritoneal dialysis patients
Scientific Title
Verification of the effect of sacubitril valsartan sodium hydrate on the residual renal function of peritoneal dialysis patients
Scientific Title:Acronym
Verification of the effect of sacubitril valsartan sodium hydrate on the residual renal function of peritoneal dialysis patients
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 effect of sacubitril valsartan sodium hydrate on the residual renal function of peritoneal dialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the rate of decrease in residual renal function in each group after 6 months of distribution to 3 groups.
Key secondary outcomes
Comparison of blood pressure in each group after 6 months of distribution to 3 groups
.Comparison of cardiac function (EF) by Biplane Modified Simpson method in each group after 6 months of 3 groups.Comparison of peritoneal function in each group after 6 months of distribution to 3 groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Test group: Sacubitril valsartan sodium hydrate use group.
Interventions/Control_2
ARB group: RAS inhibitor use group.
Interventions/Control_3
Control group: Sacubitril valsartan sodium hydrate and no RAS inhibitor.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This study targets peritoneal patients who are visiting the International University of Health and Welfare Hospital, the International University of Health and Welfare Narita Hospital, and the Keio University Hospital, and who have consented to participate in the study.Patients should be less than 3 months after the introduction of peritoneal dialysis.
Key exclusion criteria
Those who did not consent to participate in the study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Washida |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Nephrology
Zip code
286-8520
Address
IUHW Narita Hospital 852 Hatakeda, Narita City, Chiba 286-8520 Japan
TEL
0476-35-5600
washida@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Sugita |
Organization
International University of Health and Welfare
Division name
Kidney Internal Medicine Course
Zip code
329-2763
Address
537-3 Iguchi, Nasushiobara City, Tochigi Prefecture
TEL
08031522251
Homepage URL
ksugita0425@yahoo.co.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
537-3 Iguchi, Nasushiobara City, Tochigi Prefecture
Tel
08031522251
ksugita0425@yahoo.co.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 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 01 | Day |
Last modified on
| 2024 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054961
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/07/02 | エンレスト研究企画書：成田病院修正版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
