UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000012826
Receipt number	R000014881
Scientific Title	The efficacy of the healthy food containing an extract prepared from Actinidia arguta, in decreasing symptoms of pruritus in hemodialysis patients
Date of disclosure of the study information	2014/01/12
Last modified on	2014/01/11 15:26:13

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Basic information

Public title

The efficacy of the healthy food containing an extract prepared from Actinidia arguta, in decreasing symptoms of pruritus in hemodialysis patients

Acronym

The efficacy of an water soluble extract prepared from Actinidia arguta in hemodialysis patients with pruritus

Scientific Title

The efficacy of the healthy food containing an extract prepared from Actinidia arguta, in decreasing symptoms of pruritus in hemodialysis patients

Scientific Title:Acronym

The efficacy of an water soluble extract prepared from Actinidia arguta in hemodialysis patients with pruritus

Region

Japan

Condition

pruritus in hemodialysis patients

Classification by specialty

Medicine in general Nephrology Dermatology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To evaluate the effect of tablets contain an water soluble extract prepared from Actinidia arguta on the decrease of the level of risk factors for allergy such as ECP(Eosinophilic cathionic protein) and symptoms of pruritus.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Assessment

Primary outcomes

1, Evaluate the effect in decreasing symptoms of pruritus measured by VAS(Visual analogue scale).
2, Changes in the level of IgE in the blood
3, Changes in the number of eosinophils in the blood
4, Changes in the level of ECP (Eosinophil Cationic Protein)

Key secondary outcomes

1, Changes in the level of phosphorus and potassium
2, Changes in the level of intact-PTH
3, Changes in the value of blood test and urine test

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

tablets contain an water soluble extract prepared from Actinidia arguta

Interventions/Control_2

placebo

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1, Age: Men and women 20 years old and older
2, Hemodialysis patients with symptomatic pruritus

Key exclusion criteria

1, Level of IgE in the blood: under 50 IU/mL 2, Patients with i-PTH of 500pg/ml and above in the past one month.
3, Patients who had parathyroidectomy in the past 6 months of int the study
4, Patients with allergy to kiwi fruits
5, Patients in asthma care.
6, Patients in the cancer treatment
7, Patients with a history of kidney transplant 8, Patients who are pregnant or to be pregnant within three months
9, Patients with severe mental disorder
10, Patients who are scheduled to commence of Nalfurafine Hydrochloride and/or Antihistamic drug of int. the study.
11, Patients who are unsuitable to the study at a physician's discretion

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yoshie Kusano

Organization

Chuou Naika Clinic

Division name

Internal Medicine

Zip code

Address

1-4-40 Hiroekimae, Kure, Japan

TEL

81-823-71-8585

Email

rdimmuno-group@umin.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Yurina Ono

Organization

2014 PG3S Secretariat (c/o Amano Kinen Clinic)

Division name

Secretariat

Zip code

Address

4-3-6, Kaminagoya, Nishi-ku, Nagoya

TEL

81525212788

Homepage URL

Email

ymizuno@jmks-med.or.jp

Sponsor or person

Institute

Chuou Naika Clinic

Institute

Department

Personal name

Funding Source

Organization

SBI Biotech Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 12 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

2013 Year 12 Month 01 Day

Date of IRB

Anticipated trial start date

2014 Year 01 Month 13 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2014 Year 01 Month 11 Day

Last modified on

2014 Year 01 Month 11 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014881

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name