UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035060
Receipt number R000039935
Scientific Title A preliminary study to evaluate the preservation effects on renal function
Date of disclosure of the study information 2020/02/28
Last modified on 2023/06/12 08:11:38

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Basic information

Public title

A preliminary study to evaluate the preservation effects on renal function

Acronym

A preliminary study to evaluate the preservation effects on renal function

Scientific Title

A preliminary study to evaluate the preservation effects on renal function

Scientific Title:Acronym

A preliminary study to evaluate the preservation effects on renal function

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Subject enrollment for a clinical study to evaluate the preservation effects on renal function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Albumin/CRE in urinalysis

Key secondary outcomes

Blood pressure
Glucose in blood analysis
L-FABP in urinalysis
NAG in urinalysis
KIM-1 in urinalysis
Angiotensinogen in urinalysis
NGAL in urinalysis


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Urinalysis
Blood analysis
Physical examination (height, body weight, blood pressure, pulse rate)
Medical interview

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

45 years-old <=

Age-upper limit

74 years-old >=

Gender

Male

Key inclusion criteria

1) Males between the ages of 45 and 74 years old as of March 1, 2019
2) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent

Key exclusion criteria

1) Subjects who take medicines having the effect on the present study (diuretics, antihypertensive agents, SGLT2 inhibitors, warfarin, uricosuric agents, etc.)
2) Subjects who take foods for specified health uses, foods with function claims labeled or supplements (reducing triglycerides, blood pressure, blood glucose and having the effects on dysuria) which can affect the data in a main study
3) Subjects with dysuria who cannot collect their urine
4) Subjects receiving a medical history of serious liver disorder, renal disorder or heart diseases
5) Subjects receiving a medical treatment or having a medical history of hepatitis
6) Subjects who have terrible anemia
7) Subjects who have addiction to alcohol
8) Subjects who need assistance by others and who cannot walk independently
9) Subjects who are bleeding (hemophilia, capillary vulnerability, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.)
10) Subjects who have the possibility of developing allergic symptoms by the test food
11) Subjects having a medical history of hypersensitivity to the test food
12) Subjects currently participating in other clinical trials or planning to participate in other clinical trials during the examination period
13) Subjects deemed unsuitable by the investigator

Target sample size

550


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Kokaji

Organization

Maruha Nichiro Corporation

Division name

Central Research Institute

Zip code


Address

16-2, Wadai, Tsukuba, Ibaraki

TEL

029-864-6708

Email

s-kokaji@maruha-nichiro.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiro Sugino

Organization

Soiken Inc.

Division name

R&D Division

Zip code


Address

Senri Life Science Center 13F,1-4-2,Shinsenre-higashimachi, Toyonaka,Osaka

TEL

06-6871-8888

Homepage URL


Email

sugino@soiken.com


Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2020 Year 02 Month 28 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

Completed

Date of protocol fixation

2018 Year 10 Month 08 Day

Date of IRB

2018 Year 10 Month 20 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 11 Month 28 Day

Last modified on

2023 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039935


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name