UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009549
Receipt number R000011204
Scientific Title Azilsartan can restore circadian rhythm of the urinary sodium excretion
Date of disclosure of the study information 2012/12/14
Last modified on 2017/11/03 23:06:36

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Azilsartan can restore circadian rhythm of the urinary sodium excretion

Acronym

Azilsartan & Sodium Balance

Scientific Title

Azilsartan can restore circadian rhythm of the urinary sodium excretion

Scientific Title:Acronym

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

1st name
Middle name
Last name Michio FUKUDA

Organization

Nagoya City University Hospital

Division name

Division of Nephrology

Zip code


Address

Nagoya 467-8601, Japan

TEL

81-52-853-8221

Email

m-fukuda@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Michio FUKUDA

Organization

Nagoya City University Hospital

Division name

Division of Nephrology

Zip code


Address

Nagoya 467-8601, Japan

TEL

81-52-853-8221

Homepage URL


Email

m-fukuda@med.nagoya-cu.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol

http://www.med.nagoya-cu.ac.jp/cr.dir/

Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Twenty patients has been enrolled to the study.

Published on Physiological Report

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

Completed

Date of protocol fixation

2012 Year 12 Month 10 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011204


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name