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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009938
Receipt No. R000011590
Scientific Title Relationship among intrarenal renin-angiotensin system activity, circadian variation of blood pressure and renal damage by salt laoding for chronic kidney disease patients
Date of disclosure of the study information 2013/02/04
Last modified on 2019/08/10

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Basic information
Public title Relationship among intrarenal renin-angiotensin system activity, circadian variation of blood pressure and renal damage by salt laoding for chronic kidney disease patients
Acronym Relationship among intrarenal RAS activity, circadian variation of BP and renal damage by salt laoding for CKD patients
Scientific Title Relationship among intrarenal renin-angiotensin system activity, circadian variation of blood pressure and renal damage by salt laoding for chronic kidney disease patients
Scientific Title:Acronym Relationship among intrarenal RAS activity, circadian variation of BP and renal damage by salt laoding for CKD patients
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Chronic kidney disease is a risk factor for end-stage renal disease as well as cardiovascular disease. It is known that two distinct renin-angiotensin system (RAS) exist: the circulating RAS that controls blood pressure and circulating fluid volume and intrarenal RAS that is associated with renal damage. Salt intake correlates positively with blood pressure. On the other hand, salt intake is positively associated with cardiac hypertrophy and microalbuminuria that suggest cardiac and renal damage, independently of blood pressure.
We have already clarified that urinary angiotensinogen (AGT) excretion levels of CKD patients are higher than those of healthy subjects, and that urinary AGT excretion of CKD patients whose sleeping type is riser, is not decreased during nighttime compared with daytime. However, the relationship among activation of intrarenal renin-angiotensin system, circadian rhythm of blood pressure and renal damage by salt loading for chronic kidney disease patients is unclear. Therefore, this study is performed to clarify the relationship.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of urinary sodium excretion, intrarenal RAS activity, renal damage and blood pressure between normal and low salt diets
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
Food
Interventions/Control_1 After admission for renal biopsy, salt diet of 10 g/day is fed for one week. Next day, blood pressure is measured every 30 minutes during 24 hours, blood is taken at 6 a.m. and 9 p.m., and urine is collected for both daytime (6 a.m. to 9 p.m.) and nighttime (9 p.m. to 6 a.m.), respectively. Thereafter, salt loading is changed to 6 g/day. One week later, blood pressure is measured and blood and urine are collected in the same way.
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
80 years-old >
Gender Male and Female
Key inclusion criteria CKD patients that have stage 1 to 3 and urinary protein < 1.0 g/day, irrespective of causes
Key exclusion criteria CKD patients that have stage 4 to 5 and/or urinary protein >= 1.0 g/day
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Naro
Middle name
Last name Ohashi
Organization Hamamatsu University School of Medicine
Division name First Department of Medicine
Zip code 431-3192
Address 1-20-1 Handayama Higashi-ku Hamamatsu, 431-3192, Japan
TEL 053-435-2261
Email ohashi-n@hama-med.ac.jp

Public contact
Name of contact person
1st name Naro
Middle name
Last name Ohashi
Organization Hamamatsu University School of Medicine
Division name First Department of Medicine
Zip code 431-3192
Address 1-20-1 Handayama Higashi-ku Hamamatsu, 431-3192, Japan
TEL 053-435-2261
Homepage URL
Email ohashi-n@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientic Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hamamatsu University School of Medicine
Address 1-20-1 Handayama Higashi-ku Hamamatsu, 431-3192, Japan
Tel 0534352972
Email kenkyou@hama-med.ac.jp

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
2013 Year 02 Month 04 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 32
Results
    When these parameters were compared 
between the standard and low salt diets, no significant differences were found.
    This is due to small differences 
between the standard diet (10 g/day) and 
low salt diet (6 g/day).  Moreover, 
actual sodium intake was 7.53 g/day 
during the standard salt diet and 5.28 g/day during the low salt diet.  
Pickled ume and Japanese pickle, including 
abundant salt, were served, and some 
patients did not eat them.
Results date posted
2019 Year 08 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
    We recruited 32 patients with chronic 
kidney disease who had been admitted to 
Hamamatsu University School of Medicine 
Hospital.   
Participant flow
    Either a standard salt diet (10 g/day 
of salt) or low salt diet (6 g/day of 
salt) was provided after admission.  The 
examinations were performed after a 
certain period of salt diet.  
Subsequently, some patients moved from a 
standard salt diet to low salt diet and 
some patients moved from low salt diet to a standard diet, and the examinations 
were repeated after a certain period of 
salt diet.
Adverse events
Outcome measures
    The levels of urinary angiotensinogen 
(AGT) excretion as a surrogate marker of 
intrarenal renin-angiotensin system (RAS), 
urinary protein or albumin excretion as a 
surrogate marker of renal damage and blood 
pressure were evaluated.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 01 Month 23 Day
Date of IRB
2013 Year 01 Month 23 Day
Anticipated trial start date
2013 Year 02 Month 04 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 03 Day
Last modified on
2019 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011590

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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