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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000000680
Receipt No. R000000816
Scientific Title Association among mortality, risk factors and polymorphisms related to immune dysfunction (NISE study; Nagoya immune system in ESRD study)
Date of disclosure of the study information 2007/04/17
Last modified on 2019/10/28

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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/ctr_e/ctr_view.cgi?recptno=R000000816

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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