UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014060 |
|---|---|
| Receipt number | R000016371 |
| Scientific Title | Calcium channel blocker can attenuate the effect of Aldosterone on the ENaC |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2015/09/22 09:20:50 |
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Basic information
Public title
Calcium channel blocker can attenuate the effect of Aldosterone on the ENaC
Acronym
ENac function during the CCB treatment
Scientific Title
Calcium channel blocker can attenuate the effect of Aldosterone on the ENaC
Scientific Title:Acronym
ENac function during the CCB treatment
Region
| Japan |
Condition
Condition
CKD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of high dose ARB, and 3 different CCBs on the ENaC function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma Aldosterone Concentration, urinary potassium/sodium excretion ratio, trans-tubular potassium concentration gradient (TTKG)
Key secondary outcomes
Serum potassium concentration, sympathetic activity, intrarenal renin-angiotensin system activity, oxidative stress
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
olmesartan 20mg to 40mg/day
Interventions/Control_2
olmesartan 20mg to olmesartan 20mg+amlodipine 5mg/day
Interventions/Control_3
olmesartan 20mg to olmesartan 20mg+benidipine 4mg/day
Interventions/Control_4
olmesartan 20mg to olmesartan 20mg+azelnidipine 16mg/day
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) CKD, age ≥16y
2) preceding treatment with olmesartan (20mg/day) at least 8 weeks before enrollment
3) office BP ≥130/80 mmHg at 2 different visits
4) documented informed concent
Key exclusion criteria
1) preceding treatment with CCB 4-week before enrollment
2) contra indications for study medications
3) presence/possibility for pregnancy/lactation
4) HbA1c ≥9.0%
5) GOT >100, or GPT >85
6) endocrine hypertension
7) accelerated or malignant hypertension
8) serious conditions with congestive heart failure, coronary diseases, arrhythmia or systemic diseases
9) any reason for ineligibility suggested by the attending doctor
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio FUKUDA |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Cardio-Renal Medicine and Hypertension
Zip code
Address
1 kawasumi, Mizuho-ku, Nagoya 467-8601, Japan
TEL
81-52-853-8221
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 Graduate School of Medical Sciences
Division name
Department of Cardio-Renal Medicine and Hypertension
Zip code
Address
1 kawasumi, Mizuho-ku, Nagoya 467-8601, Japan
TEL
81-52-853-8221
Homepage URL
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | Month | 26 | 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
Five patients were enrolled.
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
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | 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
| 2014 | Year | 05 | Month | 25 | Day |
Last modified on
| 2015 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016371
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
