UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000680 |
|---|---|
| Receipt number | 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 10:01:04 |
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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
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
kato07@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000816
