UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022877 |
|---|---|
| Receipt number | R000025447 |
| Scientific Title | Research on granules of neutrophils and development of kidney disease |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2020/01/09 08:21:16 |
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Basic information
Public title
Research on granules of neutrophils and development of kidney disease
Acronym
Neutrophils and kidney disease
Scientific Title
Research on granules of neutrophils and development of kidney disease
Scientific Title:Acronym
Neutrophils and kidney disease
Region
| Japan |
Condition
Condition
1. Patients with kidney disease
2. Healthy donors (without any kidney diseases)
Classification by specialty
| Nephrology | Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Function of neutrophilic granule proteins and their association has been not fully understood. It can affect development of kidney diseases. The aim of this study is to reveal function and association of neutrophilic proteins.
Basic objectives2
Others
Basic objectives -Others
1. Changes in neutrophilic granule proteins according to aging.
2. Differences in neutrophilic granule proteins between healthy control and patients with kidney disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantification of Neutrophilic granule protein. In vitro effects of cell death of neutrophils.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with kidney disease:
Healthy controls:
Key exclusion criteria
People who the researchers do not judge applicapable.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Tsukuba
Division name
Department of Nephrology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL
029-853-3202
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Nagai |
Organization
University of Tsukuba Hospital
Division name
Department of Nephrology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL
029-853-3202
Homepage URL
http://www.tsukuba-igaku-kidney.com/
knagai@md.tsukuba.ac.jp
Sponsor or person
Institute
Japan Society for the Promotion of Science(JSPS)
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science(JSPS), KAKENHI Grant ID:00734352 (Grant number was not determined on Apr 2016) Grant-in-Aid for Young Scientists (B)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
Tel
029-853-3202
knagai@md.tsukuba.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
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
Results
We compared the expression level of neutrophil cytoplasmic proteins between healthy donor and patients with renal disease and found reduced expression of some kinds of protein.
Results date posted
| 2020 | Year | 01 | Month | 09 | Day |
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2016 | Year | 06 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025447
