UMIN-CTR Clinical Trial

Basic information
Public title	Association among mortality, risk factors and polymorphisms related to immune dysfunction (NISE study; Nagoya immune system in ESRD study)
Acronym	NISE study
Scientific Title	Association among mortality, risk factors and polymorphisms related to immune dysfunction (NISE study; Nagoya immune system in ESRD study)
Scientific Title:Acronym	NISE study
Region	Japan Europe

Condition
Condition	Chronic kidney disease (including end-stage renal disease)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the risk factors, especially metabolic syndrome and innate immune dysfunction, affecting mortality related to cardiovascular events and infections
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	mortality including all-cause, cardiovascular and infectious deaths, onset of cardiovascular event and infection
Key secondary outcomes	Atherosclerosis (ankle-brachial index and pulse wave velocity), malnutrition, chronic inflammation

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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)chronic kidney disease a)patients with end-stage renal disease shortly after initiation of renal replacement therapy 2)fully informed consent should be obtained
Key exclusion criteria	1)over 75 years old of age 2)acute infectious disease when entry of this study 3)severe liver dysfunction
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Shoichi Middle name Last name Maruyama
Organization	Nagoya University
Division name	Nephrology
Zip code	4548550
Address	65 Tsurumai-cho, Shouwa-ku, Nagoya city, Aichi pref. Japan
TEL	052-744-2192
Email	smatuo@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Sawako Middle name Last name Kato
Organization	Nagoya University
Division name	Nephrology
Zip code	4648550
Address	65 Tsurumai-cho, Shouwa-ku, Nagoya city, Aichi pref. Japan
TEL	052-744-2192
Homepage URL
Email	kato07@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University, Nephrology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Divisions of Renal Medicine and Baxter Novum, Department of Clinical Science, Intervention and Technology, Karolinska University Hospital Huddinge, Karolinska institute, Stockholm, Sweden
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University
Address	65 Tsurumai Showa Nagoya
Tel	052-741-2111
Email	ethics@med.nagoya-u.ac.jp

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	2007 Year 04 Month 17 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	Enrolling by invitation
Date of protocol fixation	2007 Year 04 Month 01 Day
Date of IRB	2007 Year 04 Month 01 Day
Anticipated trial start date	2007 Year 04 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	a prospective cohort study, multiple centers collaboration

Management information
Registered date	2007 Year 04 Month 17 Day
Last modified on	2019 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000816