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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023201
Receipt No. R000026230
Scientific Title Effects of L / N type Ca channel blocker cilnicipine on heart rate and QT time during hemodialysis
Date of disclosure of the study information 2016/07/16
Last modified on 2016/07/16

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Basic information
Public title Effects of L / N type Ca channel blocker cilnicipine on heart rate and QT time during hemodialysis
Acronym Effects of L / N type Ca channel blocker cilnicipine on heart rate and QT time during hemodialysis
Scientific Title Effects of L / N type Ca channel blocker cilnicipine on heart rate and QT time during hemodialysis
Scientific Title:Acronym Effects of L / N type Ca channel blocker cilnicipine on heart rate and QT time during hemodialysis
Region
Japan

Condition
Condition endstage chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of the L/N type Ca channel blocker on heart rate and QT time during hemodialysis in hemodialysis patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in heart rate or QTc during one hemodialysis session after taking L/N Ca blocker for 4 weeks
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 L-type Ca channel blocker amlodipine is administered for 4 weeks, and then it is changed to L/N-type Ca channel blocker cilnidipine.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Stable hemodialysis patients undergoing regular dialysis treatment for at least for 6 months
Key exclusion criteria acute myocardial infarction or cerebrovascular disease occurring within a half year
and atrial fibrillation
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iida Takeshi
Organization Moriguchi Keijinnkai Hospital
Division name Department of Nephrology and Dialysis
Zip code
Address 2-47-12 Yagumohigashi, Moriguchi City, 570-0021 Osaka, Japan.
TEL 06-6906-9000
Email t.iida506@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Iida Takeshi
Organization Moriguchi Keijinnkai Hospital
Division name Department of Nephrology and Dialysis
Zip code
Address 2-47-12 Yagumohigashi, Moriguchi City, 570-0021 Osaka, Japan.
TEL 06-6906-9000
Homepage URL
Email t.iida506@gmail.com

Sponsor
Institute Department of Nephrology and Dialysis, Moriguchi Keijinnkai Hospital
Institute
Department

Funding Source
Organization Moriguchi Keijinnkai Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Enrolling by invitation
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 16 Day
Last modified on
2016 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026230

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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