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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010214
Receipt No. R000011529
Scientific Title Implication of central blood pressure and renal arterio-arteriolosclerosis in chronic kidney disease (CKD) patients
Date of disclosure of the study information 2013/04/01
Last modified on 2015/06/29

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Basic information
Public title Implication of central blood pressure and renal arterio-arteriolosclerosis in chronic kidney disease (CKD) patients
Acronym Central blood pressure and renal arterio-arteriolosclerosis
Scientific Title Implication of central blood pressure and renal arterio-arteriolosclerosis in chronic kidney disease (CKD) patients
Scientific Title:Acronym Central blood pressure and renal arterio-arteriolosclerosis
Region
Japan

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

Objectives
Narrative objectives1 To investigate the relation between central blood pressure and renal arterio-arteriolosclerosis in CKD patients using the kidney tissues obtained by the renal biopsy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relation between central systolic blood pressure and renal arterio-arteriolosclerosis
Key secondary outcomes Relation between central systolic blood pressure and clinical indexes below
1) Renal histopathologic indexes (glomerulosclerosis, interstitial fibrosis/tubular atrophy, interstitial cell infiltration)
2) Cardio-ankle vascular index (CAVI)
3) Resistive index (RI) using the kidney doppler ultrasonography
4) Urinary parameters (albumin, N-acetyl-beta-glucosaminidase, beta2-microgloburin)
5) Renal function (estimated glomerular rate by creatinine and cystatin C)

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of central blood pressure
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) CKD patients who are planning to receive the renal biopsy
2) Patients with the informed consent to this study
Key exclusion criteria 1) Acute renal failure
2) Acute glomerulonephritis or rapidly progressive glomerulonephritis
3) Patients with inflammatory or consumptive diseases (e.g. infection, malignant tumor, vasculitis, collagen disease)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Komai
Organization Kawasaki Medical School
Division name Department of Nephrology and Hypertension
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192
TEL 086-462-1111
Email komai@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamehachi Namikoshi
Organization Kawasaki Medical School
Division name Department of Nephrology and Hypertension
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192
TEL 086-462-1111
Homepage URL
Email tnamikoshi@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Nephrology and Hypertension, Kawasaki Medical School
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
2013 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/nep.12483/abstract
Number of participants that the trial has enrolled
Results
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
2013 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 12 Day
Last modified on
2015 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011529

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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