UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023201 |
|---|---|
| Receipt number | 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 | 2025/01/22 13:01:10 |
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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 | Takeshi |
| Middle name | |
| Last name | Iida |
Organization
Moriguchi Keijinnkai Hospital
Division name
Department of Nephrology and Dialysis
Zip code
570-0021
Address
2-47-12 Yagumohigashi, Moriguchi City, 570-0021 Osaka, Japan.
TEL
06-6906-9000
t.iida506@gmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Iida |
Organization
Moriguchi Keijinnkai Hospital
Division name
Department of Nephrology and Dialysis
Zip code
570-0021
Address
2-47-12 Yagumohigashi, Moriguchi City, 570-0021 Osaka, Japan.
TEL
06-6906-9000
Homepage URL
t.iida506@gmail.com
Sponsor or person
Institute
Department of Nephrology and Dialysis, Moriguchi Keijinnkai Hospital
Institute
Department
Personal name
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
Moriguchi Keijinnkai Hospital
Address
2-47-12 Yagumohigashi, Moriguchi City, 570-0021 Osaka, Japan.
Tel
06-6906-9000
t.iida506@gmail.com
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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
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
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026230
