UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000022877 |
| Receipt No. | 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 (Ver. 7) |
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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 |
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| Condition | ||||
| Condition | 1. Patients with kidney disease
2. Healthy donors (without any kidney diseases) |
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| Classification by specialty |
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| 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 | |
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| Interventions/Control_7 | |
| Interventions/Control_8 | |
| Interventions/Control_9 | |
| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Patients with kidney disease:
Healthy controls: |
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| Key exclusion criteria | People who the researchers do not judge applicapable. | |||
| Target sample size | 400 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| Institute | Japan Society for the Promotion of Science(JSPS) |
| Institute | |
| Department | |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Baseline Characteristics | |||||||
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | Observational study |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025447 |
