UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between ambulatory blood pressure monitoring and renal tissue injury
Title of the study (Brief title)	ABPM and renal tissue damage
Region	Japan

Condition
Condition	glomerulonephritis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Hypertension is a common complication in chronic kidney disease patients. However, the influence of patterns of HT on renal tissue damage remains unclear.
Basic objectives2	Others
Basic objectives -Others	We investigate the relationship between ambulatory blood pressure monitoring and renal tissue injury in glomerulonephritis.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Renal tissue damage(glomerulosclerosis, interstitial fibrosis, intminal thickening of intra-lobular arteries, artriolar hyalinosis)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	over 16 years old patients with 24hr ABPM
Key exclusion criteria	patients who reject joining this study
Target sample size	100

Research contact person
Name of lead principal investigator	Nishi Shinichi
Organization	Kobe University Graduate School of Medicine
Division name	Division of Nephrology
Address	Kusunoki-cho 7-5-2, Chuou-ku, Kobe city
TEL	078-382-6500
Email	snishi@med.kobe-u.ac.jp

Public contact
Name of contact person	Kono Keiji
Organization	Kobe University Graduate School of Medicine
Division name	Division of Nephrology
Address	Kusunoki-cho 7-5-2, Chuou-ku, Kobe city
TEL	078-382-6500
Homepage URL
Email	kkono@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university graduate school of medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kobe university graduate school of medicine
Organization
Division
Category of Funding Organization	Self funding
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	神戸大学病院、明石医療センター

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 12 Day
Anticipated trial start date	2015 Year 06 Month 12 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	Published
URL releasing results
Results
Other related information	Retrospective observational study

Management information
Registered date	2015 Year 06 Month 12 Day
Last modified on	2016 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020383