UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of ciLnidipine On iNtra- and inter- Dialytic blOod pressure in iNtradialytic hypertensive patients: open-label randomized control trial
Title of the study (Brief title)	LONDON study
Region	Japan

Condition
Condition	chronic hemodialytic patients
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether cilnidipine inhibits intradialytic hypertension and sympathetic overactivity in patients with intradialytic hypertension
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intradialytic blood pressure elevation during hemodialysis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	cilnidipine
Interventions/Control_2	control
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have been on chronic hemodialysis with any causes and are older than 20 years old can be eligible for this study.
Key exclusion criteria	Patients who have pre-hemodialysis blood pressure<120 mmHg, symptom of heart failure, ischemic heart disease, malignancy disease, severe heart valve disease, or infectious disease. Patients who can not wear 24 h-ABPM.
Target sample size	60

Research contact person
Name of lead principal investigator	Masaaki Ito
Organization	Mie University Graduate School of Medicine
Division name	Cardiology and Nephrology
Address	2-174, Edobashi, Tsu, Mie, Japan
TEL	+81-59-232-1111
Email	mitoka@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Takayasu Ito
Organization	Mie University Graduate School of Medicine
Division name	Cardiology and Nephrology
Address	2-174, Edobashi, Tsu, Mie, Japan
TEL	+81-59-232-1111
Homepage URL
Email	takayasu@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
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	武内病院（三重県）、尾鷲総合病院（三重県）、遠山病院（三重県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
Anticipated trial start date	2014 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2017 Year 01 Month 20 Day

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

Management information
Registered date	2014 Year 04 Month 04 Day
Last modified on	2018 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015300