UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on 24-hour Na excretion effect of sustained ARB Azilsartan and its effect on blood pressure
Title of the study (Brief title)	Study on the effect of Na excretion and blood pressure of Azilsartan
Region	Japan

Condition
Condition	Hypertensive patients with complication of chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of 24 hours Na excretion and blood pressure on Azilsartan.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Urinary Na excretion rate
Key secondary outcomes

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	Intervention group with Azilsartan for 12days
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients over 20 years of age (2) CKD patients with hypertension thought to be unnecessary for dialysis introduction during the study period (3) Patients for whom consent is documented for participation in this study (4) Patients who have consent to hospitalization for participation in this study
Key exclusion criteria	(1) Patients who are receiving ARB, ACE inhibitors, renin inhibitors within 2 weeks (2) Patients falling under the contraindications of Azir Sultan (3) Patients with severe hypertension (4) Patients with CKDstage 5 or higher (5) patients with insulin treatment (6) Patients who are pregnant or nursing (7) Patients with severe liver dysfunction (8) Patients who are judged inappropriate for the research subject by the attending physician
Target sample size	30

Research contact person
Name of lead principal investigator	Kouichi Tamura
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Medical Science and Cardiorenal Medicine
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Email	tamukou@yokohama-cu.ac.jp

Public contact
Name of contact person	Yuki Kawai
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Medical Science and Cardiorenal Medicine
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Homepage URL
Email	ykawai2017@gmail.com

Sponsor
Institute	Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	The Salt Science Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 04 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 20 Day
Anticipated trial start date	2018 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 13 Day
Last modified on	2018 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036763