UMIN-CTR Clinical Trial

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
Email	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
Email	sh.2.komiya@gmail.com

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048577