UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030183
Receipt number R000034273
Scientific Title Effects of Nocturnal Blood Pressure Fall on the progression of Chronic Kidney Disease
Date of disclosure of the study information 2017/11/30
Last modified on 2017/11/30 10:57:09

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Basic information

Public title

Effects of Nocturnal Blood Pressure Fall on the progression of Chronic Kidney Disease

Acronym

Noctual Blood Presure and CKD

Scientific Title

Effects of Nocturnal Blood Pressure Fall on the progression of Chronic Kidney Disease

Scientific Title:Acronym

Noctual Blood Presure and CKD

Region

Japan


Condition

Condition

CKD patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effets of nocturnal blood pressure on glomerular filtration rate

Basic objectives2

Others

Basic objectives -Others

Effets of proteinuria and ANP on glomerular filtration rate

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

rate of decline of the estimated glomerular filtration rate

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

CKD patients (eGFR < 60ml/min/m2) who were admitted to our facility for a renal educational program between March 1, 2013 and August 31, 2015.

Key exclusion criteria

Patients who were under steroid therapy, diagnosed with autosomal dominant polycystic kidney disease, followed for less than 3 months.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Seta

Organization

National Hospital Organization
Kyoto Medical Center

Division name

Department of Nephrology

Zip code


Address

1-1 Mukaihata-cho, Fukakusa, Fushimi-ku,Kyoto-shi,Kyoto

TEL

075-641-9161

Email

kseta@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Seta

Organization

National Hospital Organization Kyoto Medical Center

Division name

Department of Nephrology

Zip code


Address

1-1 Mukaihata-cho, Fukakusa, Fushimi-ku,Kyoto-shi,Kyoto

TEL

075-641-9161

Homepage URL


Email

kseta@hotmail.com


Sponsor or person

Institute

National Hospital Organization
Kyoto Medical Center
Department of Nephrology

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization
Kyoto Medical Center
Department of Nephrology

Organization

Division

Category of Funding Organization

Other

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

2017 Year 11 Month 30 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


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

2016 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We retrospectively assessed the relationship between nocturnal BP fall and the rate of decline of the estimated glomerular filtration rate (eGFR) among CKD patients (eGFR < 60 ml/min/m2)


Management information

Registered date

2017 Year 11 Month 30 Day

Last modified on

2017 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034273


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name