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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001788
Receipt No. 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

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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
Email 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
Email m-fukuda@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002158

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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