UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Nocturnal Blood Pressure Fall on the progression of Chronic Kidney Disease
Title of the study (Brief title)	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	Koichi Seta
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Nephrology
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	Koichi Seta
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Nephrology
Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku,Kyoto-shi,Kyoto
TEL	075-641-9161
Homepage URL
Email	kseta@hotmail.com

Sponsor
Institute	National Hospital Organization Kyoto Medical Center Department of Nephrology
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034273