UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000009938
Receipt number	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 11:27:03

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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

Chronic kidney disease

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

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

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

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 or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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

Value
https://center6.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