UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010214
Receipt number 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 09:09:44

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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 or person

Institute

Department of Nephrology and Hypertension, Kawasaki Medical School

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


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

Value
https://center6.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