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

Email

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/

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name