UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014034 |
|---|---|
| Receipt number | R000016343 |
| Scientific Title | Synergy Effect of the ARB plus HCTZ Combination therapy on Na dynamics in CKD |
| Date of disclosure of the study information | 2014/05/22 |
| Last modified on | 2015/09/22 09:19:22 |
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Basic information
Public title
Synergy Effect of the ARB plus HCTZ Combination therapy on Na dynamics in CKD
Acronym
Synergy Effect of ARB/HCTZ Combination on Na dynamics
Scientific Title
Synergy Effect of the ARB plus HCTZ Combination therapy on Na dynamics in CKD
Scientific Title:Acronym
Synergy Effect of ARB/HCTZ Combination on Na dynamics
Region
| Japan |
Condition
Condition
Chronic kidney disease(CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the condition in which the synergy effect of ARB/HCTZ combination therapy on the natriuresis can be promised.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Changes in the tubular sodium load (PNa x GFR), tubular sodium reabsorption, and urinary sodium excretion, circadian rhythms of blood pressure and natriuresis
Key secondary outcomes
Urinary angiotensinogen excretion (intrarenal RAS activity), ultrasonic examination of the kidney (RI), heart rate variability obtained by holter ECG (sympathetic activity)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
additional medication of losartan (50mg/d) for 2 months to the preceding 2 month-treatment with HCTZ (12.5mg/d)
Interventions/Control_2
additional medication of HCTZ (12.5mg/d) for 2 months to the preceding 2 month-treatment with losartan (50mg/d)
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
1. age 20y or more
2. CKD based on K/DOQI criteria
3. Office BP >130/80 on at least one occasion before enrollment
4. documented informed consent
Key exclusion criteria
1. previous treatment with ARB or diuretics 2 months before enrollment
2. contraindication to losartan or HCTZ (history of the allergic reaction, bilateral renal artery stenosis)
3. presence or possibility of pregnancy
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. nephrotic syndrome (serum albumin <2.5 g/dl)
10. patients under hemodialysis therapy
11. any reason for ineligibility suggested by the attending doctor
Target sample size
40
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
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 | Toshiyuki Miura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Cardio-Renal Medicine and Hypertension
Zip code
Address
1 Kawasumi, Mizuho-ku, Nagoya 467-8601, Japan
TEL
81-52-853-8221
Homepage URL
tmiura@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
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
名古屋市立大学病院 Nagoya City University Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
http://www.med.nagoya-cu.ac.jp/cr.dir/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
start-up meeting held.
none 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
| 2014 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 22 | 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=R000016343
| Research Plan | |
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| 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 |
