UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003870
Receipt number R000004657
Scientific Title Intrarenal RAAS Activity can Modify Circadian Blood Pressure Rhythm in CKD
Date of disclosure of the study information 2010/07/08
Last modified on 2012/09/30 22:02:32

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Basic information

Public title

Intrarenal RAAS Activity can Modify Circadian
Blood Pressure Rhythm in CKD

Acronym

Intrarenal RAAS & Non-dipper

Scientific Title

Intrarenal RAAS Activity can Modify Circadian
Blood Pressure Rhythm in CKD

Scientific Title:Acronym

Intrarenal RAAS & Non-dipper

Region

Japan


Condition

Condition

Chronic Kidney Disease (CKD)

Classification by specialty

Cardiology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To address renal mechanism for non-dipper circadian rhythm of blood pressure (BP), we have postulated that both reduced glomerular ultrafiltration coefficient and enhanced tubular sodium reabsorption cause high sodium-sensitivity resulting in the defect in sodium excretory capacity. This in turn makes BP elevated during the night (non-dipper) in order to compensate for diminished natriuresis during daytime, thereby causing enhanced pressure natriuresis during the night. In fact, for patients with insulin resistance, diabetes mellitus, metabolic syndrome, and primary aldosteronism, non-dipper BP rhythm was noted despite preserved renal function. We also reported in patients with biopsy-proved glomerular diseases, as renal function deteriorated, nighttime BP was elevated. However, among these patients, some showed non-dipper BP rhythm even with preserved renal function. Consistent with this theory, we found that angiotensin receptor blocker could restore non-dipper circadian BP rhythm accompanied by increase in daytime natriuresis. We previously showed that the intrarenal activation of renin-angiotensin-aldosterone system (RAAS), which may stimulate tubular sodium reabsorption, could be caused by the augmentation of proximal tubular angiotensinogen (AGT) expression. Therefore, this study was performed to examine whether subjects with non-dipper BP rhythm showed increased AGT expression in renal proximal tubules in patients with CKD.

Basic objectives2

Others

Basic objectives -Others

Test the physiologic condition with no treatment.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Examine whether subjects with non-dipper rhythms of BP and natriuresis showed increased AGT expression in renal biopsy specimens (especially in proximal tubules) accompanied by enhanced tubular sodium reabsorption in patients with CKD.

Key secondary outcomes

24h BPs, glomerular filtration rate (GFR)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

The subjects were patients with CKD, who underwent renal biopsy, 24h-ABPM, and urinary sampling for daytime and night-time under hospitalization at Nagoya City University Hospital.

Key exclusion criteria

1) Usage of antihypertensive agents, imcluding diuretics and RAAS inhibitors.
2) Increase in the dosages of steroids or immunosuppressor for 2 months before renal biopsy
3) Nephrotic syndrome with severe edema

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michio Fukuda

Organization

Nagoya City University

Division name

Cardio-Renal Medicine and Hypertension

Zip code


Address

1 Kawasumi, Mizuho-ku, Nagoya 467-8601, Japan

TEL

+81-52-853-8221

Email



Public contact

Name of contact person

1st name
Middle name
Last name Michio Fukuda

Organization

Nagoya City University

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


Email

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


Sponsor or person

Institute

Nagoya City University Cardio-Renal Medicine and Hypertension

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

Department of Physiology and Hypertension and Renal Center of Excellence, Tulane University Health Sciences Center

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

名古屋市立大学病院(愛知県)


Other administrative information

Date of disclosure of the study information

2010 Year 07 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Tubular sodium reabsorption is stimulated by intrarenal angiotensin II, as indicated by proximal tubular AGT, and contributes to the genesis of the non-dipper BP rhythm (J Hypertens 30:1453-1459, 2012).

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

Completed

Date of protocol fixation

2010 Year 01 Month 27 Day

Date of IRB


Anticipated trial start date

2010 Year 02 Month 01 Day

Last follow-up date

2010 Year 07 Month 01 Day

Date of closure to data entry

2011 Year 06 Month 01 Day

Date trial data considered complete

2011 Year 07 Month 01 Day

Date analysis concluded

2011 Year 07 Month 01 Day


Other

Other related information

Retrospective Cohort Study


Management information

Registered date

2010 Year 07 Month 05 Day

Last modified on

2012 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name