UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042560 |
|---|---|
| Receipt number | R000048577 |
| Scientific Title | The renal protective effects of exerenone in hypertensive patients with CKD. |
| Date of disclosure of the study information | 2020/11/26 |
| Last modified on | 2020/11/26 12:33:49 |
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Basic information
Public title
Randomized controlled trials of the renal protective effects of exerenone versus hydrochlorothiazide in hypertensive patients with CKD already on ACEI or ARB therapy.
Acronym
The renal protective effects of exerenone in hypertensive patients with CKD.
Scientific Title
The renal protective effects of exerenone in hypertensive patients with CKD.
Scientific Title:Acronym
The renal protective effects of exerenone in hypertensive patients with CKD.
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacies of the renal protective effects of exerenone in hypertensive patients with CKD already on ACEI or ARB therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change in urinary protein
Key secondary outcomes
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
Add oral esaxerenone 1.25~2.5mg/day to the conventional therapy for 12 week
Interventions/Control_2
Add oral hydrochlorothiazide 6.25~12.5mg/day to the conventional therapy for 12 week
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
1)Patients 20 years and over
2)125/75mmHg or more at home blood pressure
3)CKD stage3
4)Urine protein 0.15g/gCr or more
5)Taking ARB/ACEI
Key exclusion criteria
1)Pations with Secondary hypertension except renal parenchymal hypertension
2)Serum potassium 5mEq/L or higher
3)Nephrotic syndrome and active nephritis
4)Taking aldosterone antagonist
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuhito |
| Middle name | |
| Last name | Hirawa |
Organization
Yokohama City University Medical Center
Division name
Department of Nephrology and Hypertension
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, Japan
TEL
045-261-5656
hirawa@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Komiya |
Organization
Yokohama City University Medical Center
Division name
Department of Nephrology and Hypertension
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, Japan
TEL
045-261-5656
Homepage URL
sh.2.komiya@gmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
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
Yokohama City University Hospital Clinical Trial Review Committee
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
Tel
045-787-2714
chiken@yokohama-cu.ac.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
| 2020 | Year | 11 | Month | 26 | 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
| 2020 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2020 | Year | 11 | Month | 26 | Day |
Last modified on
| 2020 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048577
