UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Azilsartan can restore circadian rhythm of the urinary sodium excretion
Title of the study (Brief title)	Azilsartan & Sodium Balance
Region	Japan

Condition
Condition	Chronic Kidney Disease (CKD)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the increase in daytime natriuresis (UNaV) can precede the restoration of circadian BP rhythm
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate whether night/day UNaV ratio reduce to <1.0 before the night/day BP ratio reduce to <0.9
Key secondary outcomes	GFR, Urinary excretion of albumin, potassium, chrolide, angiotensinogen and 8-OHdG, HF and LF/HF obtained by Holter ECG,safety Circadian BP rhythm 1 year after treatment was also studied.

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	oral administration of Azilsartan once in the morning
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. received medical care at Nagoya City University Hospital 2. UNaV of 85-120mmol/day at least 3 different times 4 wks before enrollement 3. CKD criteria based on K/DOQI 4. need for Azilsartan 5. documented informed concent
Key exclusion criteria	1. previous treatment with ARB, or diuretics 2 months before enrollment 2. change in the antihypertensive medication 2 months before enrollment 3. contraindication to Azilsartan (history of allergic reaction to it, bilateral renal artery stenosis) 4. presence or possibility of pregnancy/lactation 5. HbA1c >9.0 % 6. GOT >100, or GPT >85 7. endocrine hypertension 8. accelerated o r malignant hypertension (progressive renal dysfunction with diastolic BP of >120-130 mmHg 9. serious conditions with congestive heart failure, coronary diseases, arrhythmia or systemic diseases 10. nephrotic syndrome (serum albumin <2.5 g/dl) 11. any reason for ineligibility suggested by the attending doctor
Target sample size	40

Research contact person
Name of lead principal investigator	Michio FUKUDA
Organization	Nagoya City University Hospital
Division name	Division of Nephrology
Address	Nagoya 467-8601, Japan
TEL	81-52-853-8221
Email	m-fukuda@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Michio FUKUDA
Organization	Nagoya City University Hospital
Division name	Division of Nephrology
Address	Nagoya 467-8601, Japan
TEL	81-52-853-8221
Homepage URL
Email	m-fukuda@med.nagoya-cu.ac.jp

Sponsor
Institute	Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	名古屋市立大学病院 (Nagoya City University Hospital)

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 10 Day
Anticipated trial start date	2012 Year 12 Month 17 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 07 Month 31 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2016 Year 08 Month 31 Day

Related information
URL releasing protocol	http://www.med.nagoya-cu.ac.jp/cr.dir/
Publication of results	Published
URL releasing results
Results	Twenty patients has been enrolled to the study. Published on Physiological Report
Other related information

Management information
Registered date	2012 Year 12 Month 14 Day
Last modified on	2017 Year 11 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011204