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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003870
Receipt No. 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

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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
Institute Nagoya City University Cardio-Renal Medicine and Hypertension
Institute
Department

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
URL(English) https://upload.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


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