UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001788 |
|---|---|
| Receipt number | R000002158 |
| Scientific Title | Achieved timing of nocturnal BP dip by negative sodium balance with diuretics in CKD: comparison between diuretics alone and its combination with ARB. |
| Date of disclosure of the study information | 2009/03/24 |
| Last modified on | 2015/09/22 09:08:59 |
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Basic information
Public title
Achieved timing of nocturnal BP dip by negative sodium balance with diuretics in CKD: comparison between diuretics alone and its combination with ARB.
Acronym
Achieved timing of nocturnal BP dip by negative sodium balance.
Scientific Title
Achieved timing of nocturnal BP dip by negative sodium balance with diuretics in CKD: comparison between diuretics alone and its combination with ARB.
Scientific Title:Acronym
Achieved timing of nocturnal BP dip by negative sodium balance.
Region
| Japan |
Condition
Condition
Chronic kidney disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Time courses of nocturnal BP dip achieved by negative sodium balance will be compared with diuretics alone or its combination with ARB.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration in days since diuretics alone, or in combination with ARB, are administered until nocturnal BP becomes lower than 90% of daytime averages.
Key secondary outcomes
Changes in the night/day ratio of urinary albumin excretion, 24-h BP, glomerular filtration rate, daily urinary albumin excretion, HbA1c, and serum uric acid, or any adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) Pre-intervention, 2) diuretics (HCTZ 12.5mg) once in the morning for a week, and then, 3) combination of diuretics (HCTZ 12.5mg) with angiotensin II blocker (losartan 50mg) once in the morning for a week
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria include the following: 15 years of age or older; hospitalized in Nagoya City University hospital; diagnosed as having chronic kidney disease (CKD) based on K/DOQI criteria (either kidney damage or glomerular filtration of <60 mL/min/1.73m2 for 3 months or more); and written informed consent was obtained.
Key exclusion criteria
Exclusion criteria are as follows; use of inhibitors of renin-angiotensin system or diuretics 1 month before enrollment; specific contraindication to a study drug; HbA1c of 9.0 % or above; serious liver damage (GOT >100, or GPT >85); secondary hypertension; accelerated or malignant hypertension (progressive renal dysfunction with diastolic BP of >120-130 mmHg); serious congestive heart failure, coronary heart disease, arrhythmia, or systemic diseases; presence or possibility of pregnancy; or any reason for ineligibility suggested by the attending doctor.
Target sample size
5
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
Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8221
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
Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8221
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
None
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
| 2009 | Year | 03 | Month | 24 | 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
the results from interim analysis was reported in the medical conferences (2014JSN, JSH).
under reporting the dissertation
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | 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=R000002158
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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