UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	AZELNIDIPINE COMBINED WITH ANGIOTENSIN RECEPTOR BLOCKER CAN RESTORE SYMPATHETIC ACTIVITY
Title of the study (Brief title)	Azelnidipine/ARB & Sympathetic activity
Region	Japan

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

Objectives
Narrative objectives1	To determine whether the combination antihypertensive regimen, olmesartan and azelnidipine, can restore sympathetic/parasympathetic activities in patients with CKD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Decrease in LF/HF, increase in HF and the attenuation of the non-Gaussianity index during 8-wk treatment with ARB/CCB
Key secondary outcomes	changes in proteinuria (mg/gCre) and office blood pressure

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	concurrent treatment with olmesartan and azelnidipine
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	patients with CKD undergoing treatment with olmesartan for at least 2 months before enrollment no medication with calcium channel blockers for at least 2 months before enrollment
Key exclusion criteria	1) polycystic kidney disease 2) arrhythmia 3) known history of angina pectoris, myocardial infarction, heart failure, stroke, or TIA
Target sample size	20

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	Division of Nephrology, Nafoya City University Hospital
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)

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(愛知県)

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 24 Day
Anticipated trial start date	2012 Year 07 Month 25 Day
Last follow-up date	2014 Year 05 Month 31 Day
Date of closure to data entry	2014 Year 12 Month 31 Day
Date trial data considered complete	2014 Year 12 Month 31 Day
Date analysis concluded	2014 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Means of all normal-to-normal intervals over 24 h (p<0.0001) and DC (p=0.002) increased, and Lambda (p=0.001) decreased regardless of gender, age, renal function or blood pressure, while no significant changes were observed in the other HRVs. Reduction of Lambda is useful to assess the effect of sympathoinhibitory treatment. J Renin Angiotensin Aldosterone Syst. 2016 Apr 18;17(2):1470320316643905
Other related information

Management information
Registered date	2012 Year 10 Month 21 Day
Last modified on	2016 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010741